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W2019282605 abstract "The mortality rate in children with ESRD is substantially lower than the rate experienced by adults. However, the risk of death while awaiting kidney transplantation and the impact of transplantation on long-term survival has not been well characterized in the pediatric population. We performed a longitudinal study of 5961 patients under age 19 who were placed on the kidney transplant waiting list in the United States. Of these, 5270 received their first kidney transplant between 1990 and 2003. Survival was assessed via a time-varying nonproportional hazards model adjusted for potential confounders. Transplanted children had a lower mortality rate (13.1 deaths/1000 patient-years) compared to patients on the waiting list (17.6 deaths/1000 patient-years). Within the first 6 months of transplant, there was no significant excess in mortality compared to patients remaining on the waiting list (adjusted Relative Risk (aRR) = 1.01; p = 0.93). After 6 months, the risk of death was significantly lower: at 6–12 months (aRR = 0.37; p < 0.001) and at 30 months (aRR 0.26; p < 0.001). Compared to children who remain on the kidney transplant waiting list, those who receive a transplant have a long-term survival advantage. With the potential for unmeasured bias in this observational data, the results of the analysis should be interpreted conservatively.This study used epidemiologic data from the USRDS to determine the associated risk factors for death and mortality rates among children waiting for their first kidney transplant. See also editorial by Delmonico in this issue on page 2487. The mortality rate in children with ESRD is substantially lower than the rate experienced by adults. However, the risk of death while awaiting kidney transplantation and the impact of transplantation on long-term survival has not been well characterized in the pediatric population. We performed a longitudinal study of 5961 patients under age 19 who were placed on the kidney transplant waiting list in the United States. Of these, 5270 received their first kidney transplant between 1990 and 2003. Survival was assessed via a time-varying nonproportional hazards model adjusted for potential confounders. Transplanted children had a lower mortality rate (13.1 deaths/1000 patient-years) compared to patients on the waiting list (17.6 deaths/1000 patient-years). Within the first 6 months of transplant, there was no significant excess in mortality compared to patients remaining on the waiting list (adjusted Relative Risk (aRR) = 1.01; p = 0.93). After 6 months, the risk of death was significantly lower: at 6–12 months (aRR = 0.37; p < 0.001) and at 30 months (aRR 0.26; p < 0.001). Compared to children who remain on the kidney transplant waiting list, those who receive a transplant have a long-term survival advantage. With the potential for unmeasured bias in this observational data, the results of the analysis should be interpreted conservatively. This study used epidemiologic data from the USRDS to determine the associated risk factors for death and mortality rates among children waiting for their first kidney transplant. See also editorial by Delmonico in this issue on page 2487. Kidney transplantation is widely accepted as the optimal treatment modality for children with chronic kidney disease (CKD) stage 5. In the United States, children awaiting kidney transplantation are given priority over adults for organ allocation in an effort to reduce the time to transplantation, improve access of pediatric patients to high-quality allografts and mitigate the suboptimal growth and development caused by kidney failure (1McDiarmid SV. United Network for Organ Sharing rules and organ availability for children: Current policies and future directions..Pediatr Transplant. 2001; 5: 311-316Crossref PubMed Scopus (6) Google Scholar,2Sweet SC Wong HH Webber SA et al.Pediatric transplantation in the United States, 1995–2004..Am J Transplant. 2006; 6: 1132-1152Abstract Full Text Full Text PDF PubMed Scopus (66) Google Scholar). Data suggest that certain subgroups of children may be at higher risk of posttransplant complications, causing some uncertainty with respect to the risks and benefits of waiting longer for an optimal kidney and/or readiness of the recipient (3Smith JM Ho PL McDonald RA. Renal transplant outcomes in adolescents: A report of the North American Pediatric Renal Transplant Cooperative Study..Pediatr Transplant. 2002; 6: 493-499Crossref PubMed Scopus (142) Google Scholar,4Kennedy SE Mackie FE Rosenberg AR McDonald SP. Waiting time and outcome of kidney transplantation in adolescents..Transplantation. 2006; 82: 1046-1050Crossref PubMed Scopus (42) Google Scholar). The risk of death while awaiting kidney transplantation and the impact of kidney transplantation on long-term survival has not been well characterized in the pediatric population. The present study was designed to determine the relative risk of mortality of pediatric patients with CKD stage 5 awaiting a first kidney transplant compared to pediatric patients who receive their first kidney transplant. The research was approved by the institutional review board at the University of New Mexico Health Sciences Center. Data for the current study were obtained from the United States Renal Data System (USRDS). The USRDS contains demographic and clinical information on all US patients with end stage renal disease (ESRD) who qualify for Medicare and survive more than 90 days with renal replacement therapy. Briefly, USRDS data are generated from various sources, including Medicare billing records, UNOS transplant records, ESRD medical evidence reports (Centers for Medicare and Medicaid Services form 2728), network census reports and death notification reports. The structure of the USRDS is described in greater detail elsewhere (5United States Renal Data System.2006 Researcher’s Guide to the USRDS Database.. USRD, Minneapolis, MN2006Google Scholar). To obtain roughly comparable health status between patients receiving their first kidney transplant and those undergoing dialysis, only patients listed on the kidney transplant waiting list were included. Patients who had previously received a kidney transplant and placed on the waiting list again were excluded from the analysis. Patients placed on the kidney-pancreas and kidney-liver transplant waiting list were also excluded. Thus, data were extracted for those patients who had not undergone transplantation before January 1, 1990, and who were placed on the transplant waiting list between January 1, 1990, and December 31, 2003. Given the pediatric focus of the study, the sample population was restricted to those patients 18 years of age and younger at the time of placement onto the kidney transplant waiting list. After implementing these inclusion and exclusion criteria, data on 5961 patients were available for analysis. Dialysis modality included both peritoneal dialysis and hemodialysis (with nearly all patients younger than age 12 receiving peritoneal dialysis), and transplant modality included only kidney transplantation. Covariates that we identified a priori as potential risk factors for mortality included age at the time of placement on the transplant waiting list, sex, race (African American, Caucasian, other), primary cause of renal disease (as listed on CMMS form 2728) and the length of time undergoing dialysis before being placed on the transplant waiting list. Renal diseases were categorically grouped based on previously published USRDS data (6Wong CS Gipson DS Gillen DL Emerson S et al.Anthropometric measures and risk of death in children with end-stage renal disease..Am J Kidney Dis. 2000; 36: 811-819Abstract Full Text Full Text PDF PubMed Scopus (178) Google Scholar). Date of transplantation was abstracted from the USRDS treatment history file, which contains information regarding the history of modalities prescribed for each patient in the database. Mortality occurring during the follow-up was determined using information contained in the USRDS Core patients standard analysis file. Date of death was obtained from the Health Care Financing Administration form 2746 which is submitted to the USRDS by the patient’s nephrologists. For the current analysis, mortality data were considered complete between January 1, 1990, and December 31, 2003. Mortality rates were calculated as the observed number of deaths per total patient time at risk. Patients were considered at risk for death from the time of initial placement on the transplant waiting list until the occurrence of death, loss-to-follow-up, or December 31, 2003. In the event where no Medicare payments for renal replacement therapy were recorded for 1 year, patients were considered lost-to-follow-up from the date of the last known payment. Survival analysis was used to model time from initial placement on the waiting list until death. Transplantation was considered a terminal treatment group. That is, once patients underwent transplantation they were entered into and remained in the transplant group regardless of the status of the allograft. Based upon previous studies (7Wolfe RA Ashby VB Milford EL et al.Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant..N Engl J Med. 1999; 341: 1725-1730Crossref PubMed Scopus (3995) Google Scholar), we a priori hypothesized the presence of nonproportional hazards with respect to the association between transplantation and the risk of mortality, or that the relative risk of death associated with transplant varied with time. To model this association, a time-dependent covariate that indicated the total time each patient had been a member of the transplant group was also entered into the regression model (8Fisher LD Lin DY. Time-dependent covariates in the Cox proportional-hazards regression model..Annu Rev Public Health. 1999; 20: 145-157Crossref PubMed Scopus (618) Google Scholar). Our original regression model assumed that time since transplantation was linearly related to the log-relative risk of mortality. We further explored the validity of the linear assumption by not imposing a linear structure to the functional form of the time covariate. For this analysis, we categorized time since transplantation into 6-month intervals and modeled the covariate as a categorical predictor, allowing the relative risk associated with time since transplantation to change arbitrarily from one interval to the next. This investigation found that the linear assumption fit the data well. Adjustment covariates were included in the multivariate analysis if they were considered a priori to be potential confounders or independent risk factors for death. These included age, gender, race, primary cause of CKD and the length of time undergoing dialysis before being placed on the transplant waiting list. The length of time undergoing dialysis before being placed on the waiting list was computed for each patient using the date when the patient started dialysis and the actual date when the patient was placed onto the transplant waiting list. Given the large number of patients placed on the transplant waiting list prior to and around the initiation of dialysis, the duration of disease was categorized into three groups (prior to initiation dialysis therapy, around initiation of dialysis therapy and after initiation of dialysis therapy). Secondary analyses were performed to evaluate for the potential effect of the role of dialysis (hemodialysis vs. peritoneal dialysis) and pre-emptive transplant; type of donor (deceased donor vs. living) and cohort effects resulting from changes in patient care (techniques and medications) and transplant allocation policy changes. All statistical analyses were performed using SAS v9.3 (SAS Institute Inc., Cary, NC) and R v2.1.0. Overall, the 5961 subjects who met the inclusion criteria were more likely to be 13–18 years of age, male and Caucasian. Reflecting an older pediatric population, glomerular disease was the most common cause of CKD. The majority of patients were placed on the transplant waiting list prior to or around the time of starting dialysis therapy. A comparison of the characteristics between subjects who did and did not receive a kidney transplant over the total course of follow-up are presented in Table 1. Among those patients who received a transplant over the course of the study, the average time from placement onto the waitlist to the transplant date was approximately 7.9 months (standard deviation of 11.8 months). Relative to those patients who received a transplant, the 691 patients who did not receive a transplant during study follow-up consisted of a greater proportion of African Americans compared to Caucasians (37.2% vs. 25.7%) and nearly all (94.6%) were listed on the waitlist around the time of dialysis initiation.Table 1Patient characteristics1Totals vary due to missing data.Patient characteristicWaitlist (N = 5961)Transplant (N = 5270)Age at placement on waitlist11.25 (5.13)11.14 (5.11)5 and below813 (14.2%)743 (14.7%)6–121816 (31.7%)1632 (32.2%)13–183105 (54.2%)2695 (53.2%)GenderMale3361 (56.4%)3000 (57%)Female2597 (43.6%)2267 (43%)RaceCaucasian3911 (65.7%)3564 (67.6%)African American1610 (27%)1355 (25.7%)Other435 (7.3%)351 (6.7%)Cause of CKDGlomerular diseases2234 (37.9%)1921 (36.9%)Congenital/inherited1984 (33.7%)1793 (34.4%)Vasculitis/interstitial diseases434 (7.4%)393 (7.5%)Nephrotoxic/tumor related70 (1.2%)59 (1.1%)Other409 (6.9%)353 (6.8%)Unknown764 (13%)687 (13.2%)Time of placement on waitlist (months)2Average time between initiation of renal replacement therapy and placement onto the transplant waitlist.3.69 (22.21)4.22 (23.56)Prior to initiation of dialysis therapy1321 (22.2%)1284 (24.4%)Around initiation of wdialysis therapy4076 (68.4%)3422 (64.9%)After initiation of dialysis therapy564 (9.5%)564 (10.7%)The first column presents characteristics for all patients in the study sample. The second column presents characteristics only for those patients transplanted before the end of the follow-up. Summary statistics are presented as a mean (SD) for continuous covariates and frequency (%) for categorical covariates.1 Totals vary due to missing data.2 Average time between initiation of renal replacement therapy and placement onto the transplant waitlist. Open table in a new tab The first column presents characteristics for all patients in the study sample. The second column presents characteristics only for those patients transplanted before the end of the follow-up. Summary statistics are presented as a mean (SD) for continuous covariates and frequency (%) for categorical covariates. Table 2 yields estimated mortality rates (per 1000 patient-years) by transplant status and patient demographics. Regardless of transplant status, death rates differed by age, gender, race, primary cause of CKD and timing of placement on the waiting list. Children aged 5 years and younger experienced an approximate two-fold higher mortality rate compared to children aged 6–18 years, and females tended have a higher rate of mortality when compared to males. Lower mortality rates were observed in Caucasian children compared to other racial groups regardless of transplant status. Finally, individuals placed on the transplant waiting list following the start of renal replacement therapy had a lower mortality rate (8.4 deaths/1000 patient-years) compared to patients on the waiting list prior to or at the start of dialysis therapy, regardless of transplant status.Table 2Observed mortality rate (per 1000 patient-years) by transplant statusPatient characteristicsWaitlist (N = 5961)Transplant (N = 5270)Patient-years at riskNumber of deathsMortality rate1Per 1000 patient-years.Patient-years at riskNumber of deathsMortality rate1Per 1000 patient-years.Total18 59632817.613 60217813.1Age at study start (years)5 and below2 3127030.31 8594624.76–125 4937814.24 2084310.213–1810 14015515.37 0517510.6GenderMale10 466167167 7229912.8Female8 12916119.85 8797913.4RaceCaucasian11 91918615.69 24510611.5African American5 35911120.73 4865515.8Other1 3143022.88711719.5Primary cause of ESRDGlomerular diseases7 39712216.55 0795911.6Congenital/inherited5 97310617.74 5846213.5Vasculitis/interstitial diseases1 329118.31 00055.0Nephrotoxic/tumor related207524.2154213.0Other1 3513324.49401313.8Unknown2 09444211 6673118.6Time of placement on waitlist (months)2Time between initiation of dialysis therapy and placement onto the transplant waitlist.Prior to initiation of dialysis therapy3 6395916.23 2234714.6Around initiation of dialysis therapy13 29725519.28 72011713.4After initiation of dialysis therapy1 659148.41 659148.4The first three columns pertain to all patients in the study sample. The last three pertain only to those patients transplanted before the end of the follow-up.1 Per 1000 patient-years.2 Time between initiation of dialysis therapy and placement onto the transplant waitlist. Open table in a new tab The first three columns pertain to all patients in the study sample. The last three pertain only to those patients transplanted before the end of the follow-up. We found that patients placed on the kidney transplant waitlist (all patients in the study sample) experienced an estimated mortality rate of 17.6 deaths/1000 patient-years compared to 13.1 deaths/1000 patient-years observed in transplanted patients. Among the 691 patients who did not receive a transplant during follow-up, the estimated mortality rate was 30.0 deaths/1000 patient-years (not shown in Table 2). Without adjustment for other factors, recipients of a first kidney transplant had a lower mortality rate compared to patients on the waiting list regardless of stratification by age, gender, race or cause of ESRD. Among patients who were waitlisted prior to or at the time of ESRD therapy initiation, those transplanted had a lower mortality rate compared to patients who remained on the waiting list. In total, 3671 patients received a transplant from a deceased donor, 1581 patients received a transplant from a living related donor and 18 patients did not have information on the type of donor. Comparing mortality rates among transplanted subjects, we found no significant differences in mortality rates between allograft recipients from deceased donors and allograft recipients from living related donors (data not shown). The adjusted relative risk (aRR) of death by patient characteristics is given in Table 3. Adjustment factors included age, gender, race, cause of ESRD, when placement onto the waiting list occurred relative to the start of dialysis therapy, and the time since transplantation. The aRR of death was estimated to be lower with increasing age (aRR = 0.93, 95% CI: 0.91, 0.95; p < 0.001). Furthermore, female gender was associated with a higher risk of death (aRR = 1.27, 95% CI: 1.02, 1.59, p = 0.03). Race and timing of placement of the waiting list were not associated with risk of death.Table 3Cox regression estimates of the relative risk of mortality for all agesCovariateAdjusted relative risk1Adjusted for all covariates listed. (95% CI)p-ValueAge at study start (years)0.93 (0.91, 0.95)<0.001Gender (female vs. male)1.27 (1.02, 1.59)0.034RaceCaucasian1.0African American1.15 (0.90, 1.48)0.259Other1.31 (0.89, 1.93)0.178Primary cause of ESRD<0.001Glomerular1.0Congenital/inherited0.97 (0.73, 1.29)0.825Vasculitis/interstitial diseases0.47 (0.25, 0.90)0.022Nephrotoxic/tumor related1.47 (0.60, 3.62)0.397Other1.46 (0.99, 2.15)0.055Unknown1.31 (0.92, 1.88)0.139Time of placement on waitlistPrior to initiation of dialysis therapy1.0Around initiation of dialysis therapy0.89 (0.65, 1.21)0.462After initiation of dialysis therapy0.67 (0.37, 1.21)0.186Time since transplantNo transplant1.0Less than 6 months1.01 (0.75, 1.37)0.9286–12 months0.37 (0.24, 0.59)<0.00112–18 months0.42 (0.27, 0.67)<0.00118–24 months0.23 (0.13, 0.41)<0.00124–30 months0.20 (0.11, 0.37)<0.00130–36 months0.26 (0.14, 0.46)<0.0011 Adjusted for all covariates listed. Open table in a new tab In the nonproportional hazards analysis, an increased risk of mortality immediately after transplant was not observed in pediatric transplant patients. Relative to CKD stage 5 patients on the transplant waiting list, those patients transplanted in less than 6 months showed no difference in the risk of mortality (aRR = 1.01, 95% CI: 0.75, 1.37; p = 0.93). It was estimated that the risk of mortality in the transplant group equals that of the dialysis group approximately 30 days after transplantation (Figure 1A) and is significantly lower 6 months after transplant compared to patients remaining on the transplant waiting list for their first kidney. The relative risk of mortality comparing patients transplanted for 6–12 months to those on the waitlist was estimated to be 63% lower (aRR = 0.37; 95% CI: 0.24, 0.59; p < 0.001). The lower risk of death among pediatric and adolescent patients with kidney transplants persists at all time points past 6 months. The relative risk of mortality comparing patients transplanted greater than 30 months to those on the waitlist was estimated to be 74% lower (aRR = 0.26; 95% CI: 0.14, 0.46; p < 0.001). We performed a subanalysis to determine if the survival characteristics observed above were modified by differences in age. Table 4 and Figure 1B present aRR estimates associated with time since transplant stratified by patient age at the time of placement onto the transplant waiting list. Although we did not detect statistically significant differences in the association between transplant and the risk of death by age, among the two youngest age groups (those aged less than or equal to 5 years and those aged 6–12 years) our model-based point estimates indicated an increased risk of mortality in the time shortly following transplantation as presented in Figure 1B. In particular, among those 5 years old and younger we estimated an initial 35% higher risk of mortality immediately following transplantation and estimated that the risk of death associated with transplant was equal to that of the risk of death on the waiting list (RR = 1.0) at 179 days following transplantation (Figure 1B). Among those 6–12 years old we estimated an initial 19% higher risk of mortality immediately following transplantation and estimated that the RR = 1.0 occurred at 51 days following transplantation (Figure 1B). We did not observe an initial increase in the risk of mortality among the oldest patient group (13–18 years of age).Table 4Cox regression estimates of the adjusted relative risk of mortality stratified by age1Adjusted for all covariates listed in Table 3.Time since transplantAge 0–5Age 6–12Age 13–18No transplant1.01.01.0Less than 6 months1.28 (0.74, 2.21)0.99 (0.48, 2.04)0.90 (0.58, 1.39)6–12 months0.60 (0.26, 1.38)0.37 (0.12, 1.11)0.32 (0.16, 0.61)12–18 months0.76 (0.32, 1.79)0.29 (0.08, 1.03)0.36 (0.19, 0.69)18–24 months0.21 (0.05, 0.81)0.07 (0.01, 0.61)0.33 (0.17, 0.66)24–30 months0.32 (0.09, 1.18)0.12 (0.02, 0.62)0.23 (0.10, 0.51)30–36 months0.52 (0.14, 1.91)0.09 (0.02, 0.54)0.30 (0.15, 0.62)1 Adjusted for all covariates listed in Table 3. Open table in a new tab Table 4 presents the relative risk of mortality associated with transplantation over 6 month intervals. Within the first 6 months following the surgery, the risk of transplant-associated mortality among the very young (0–5 years of age) appeared to be 28% higher (aRR = 1.28; 95% CI 0.71, 2.21) compared to those of the same age group remaining on the waiting list. As in the combined analysis, the risk of mortality was estimated to be lower among all age groups transplanted more than 6 months when compared to patients on the waitlist. In the series of secondary analyses, there were no significant risk factors for mortality by type of dialysis therapy prior to transplant; type of donor (deceased donor vs. living related) and cohort year. We considered the role of prior dialysis therapy (hemodialysis vs. peritoneal dialysis) in the relationship between pre-emptive transplant and mortality. However, we found that nearly all patients in the younger two categories underwent peritoneal dialysis and hence controlling for ESRD therapy did not change the observed association between time of placement on the waitlist and the risk of mortality. Type of donor (deceased donor vs. living) was a priori considered to be a potential effect modifier; however, exploratory analyses revealed no statistical difference in the risk of death by donor type (data not shown). However, the study was underpowered to investigate this relationship with only 60 deaths observed among deceased donor transplant recipients. Due to potential cohort effects resulting from changes in patient care (techniques and medications) and transplant allocation, secondary analyses were stratified by date of placement onto the transplant waiting list (with cohorts defined by 5-year time intervals), but revealed no significant differences by the cohort group (data not shown). The results of this study indicate that among pediatric patients placed on the waiting list for a first kidney transplant, recipients of a kidney allograft have a long-term survival advantage compared to those who remain on the waiting list. Our data are consistent with data from both the adult and pediatric populations that have shown a survival benefit associated with kidney transplantation (6Wong CS Gipson DS Gillen DL Emerson S et al.Anthropometric measures and risk of death in children with end-stage renal disease..Am J Kidney Dis. 2000; 36: 811-819Abstract Full Text Full Text PDF PubMed Scopus (178) Google Scholar,7Wolfe RA Ashby VB Milford EL et al.Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant..N Engl J Med. 1999; 341: 1725-1730Crossref PubMed Scopus (3995) Google Scholar,9Furth SL Hwang W Yang C et al.Growth failure, risk of hospitalization and death for children with end-stage renal disease..Pediatr Nephrol. 2002; 17: 450-455Crossref PubMed Scopus (137) Google Scholar,10Wong CS Hingorani S Gillen DL et al.Hypoalbuminemia and risk of death in pediatric patients with end-stage renal disease..Kidney Int. 2002; 61: 630-637Abstract Full Text Full Text PDF PubMed Scopus (120) Google Scholar). Wolfe et al. demonstrated that patients under 70 years of age with ESRD receiving their first kidney transplant had an initial higher risk of death after transplantation followed by a lower risk of death compared to patients on the kidney transplant waiting list (7Wolfe RA Ashby VB Milford EL et al.Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant..N Engl J Med. 1999; 341: 1725-1730Crossref PubMed Scopus (3995) Google Scholar). In contrast, among pediatric CKD patients (aged 0–18 years) placed on the waiting list for their first kidney transplant, we observed no statistically significant increase in the risk of death any time after transplant. The observed differences between children and adults in the risk of death soon after kidney transplant may be explained by the difference in the causes of CKD and the associated cardiovascular disease (CVD). Being very rare causes of CKD in childhood, diabetes and hypertension are the dominant causes of CKD in adulthood and are associated with comorbid CVD (11Levey AS Beto JA Coronado BE et al.Controlling the epidemic of cardiovascular disease in chronic renal disease: What do we know? What do we need to learn? Where do we go from here? National Kidney Foundation Task Force on Cardiovascular Disease..Am J Kidney Dis. 1998; 32: 853-906Abstract Full Text PDF PubMed Scopus (839) Google Scholar). However, with the small number of events observed in these age groups our study may have been underpowered to detect statistically significant increases in risk for death shortly after surgery. In light of the inherent limitations of observational data, we cannot rule out selection bias or other unmeasured bias, though we would note that our comparison groups were selected in the same fashion as the Wolfe et al. study (7Wolfe RA Ashby VB Milford EL et al.Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant..N Engl J Med. 1999; 341: 1725-1730Crossref PubMed Scopus (3995) Google Scholar). Pediatric kidney transplantation is generally regarded the treatment of choice for the treatment of chronic kidney failure in the pediatric and adolescent population. In the recent years, the graft survival rates in the very young has been reassuring with children 1–5 years of age having the 1- and 5-year graft survival rates that are comparable to or better than all other age groups including adults (12Harmon WE McDonald RA Reyes JD et al.Pediatric transplantation, 1994–2003..Am J Transplant. 2005; 5: 887-903Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar). In our analysis of subjects 5 years of age or younger, there was a trend toward a higher risk for death within the first 6 months following transplant, but this result was not statistically significant secondary to the relatively small number of events in this group. Adolescent kidney transplant patients are at risk for medication nonadherence, poor rejection reversal outcomes and consequent decreased allograft survival (3Smith JM Ho PL McDonald RA. Renal transplant outcomes in adolescents: A report of the North American Pediatric Renal Transplant Cooperative Study..Pediatr Transplant. 2002; 6: 493-499Crossref PubMed Scopus (142) Google Scholar). In our study, subjects who underwent kidney transplant but had a subsequent allograft failure remained in the kidney transplant group. Still, we did not observe an overall increase in risk for death at any time after transplant compared to those on the waiting list. The pointwise confidence intervals (Figure 1A) suggest that after 30 days after transplant, those who have been transplanted appear to have a long-term survival advantage compared to a similar pediatric subjects remaining on the waiting list. Despite overall improved survival in all age groups associated with transplantation, we did confirm important differences in survival overall by age and gender. Comparable to previous reports (13Shroff R Rees L Trompeter R et al.Long-term outcome of chronic dialysis in children..Pediatr Nephrol. 2006; 21: 257-264Crossref PubMed Scopus (75) Google Scholar, 14McDonald SP Craig JC. Long-term survival of children with end-stage renal disease..N Engl J Med. 2004; 350: 2654-2662Crossref PubMed Scopus (609) Google Scholar, 15Leonard MB Donaldson LA Ho M Geary DF. A prospective cohort study of incident maintenance dialysis in children: An NAPRTC study..Kidney Int. 2003; 63: 744-755Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar), we found that young patients (age ≤ 5 years) were at higher risk for death compared to older pediatric patients in both the waiting list group and the transplant group. Additionally, we found that female gender was associated with a higher risk of death, which is consistent with non-significant trends observed in prior reports of smaller study populations (9Furth SL Hwang W Yang C et al.Growth failure, risk of hospitalization and death for children with end-stage renal disease..Pediatr Nephrol. 2002; 17: 450-455Crossref PubMed Scopus (137) Google Scholar,10Wong CS Hingorani S Gillen DL et al.Hypoalbuminemia and risk of death in pediatric patients with end-stage renal disease..Kidney Int. 2002; 61: 630-637Abstract Full Text Full Text PDF PubMed Scopus (120) Google Scholar,14McDonald SP Craig JC. Long-term survival of children with end-stage renal disease..N Engl J Med. 2004; 350: 2654-2662Crossref PubMed Scopus (609) Google Scholar). Although our data support a survival advantage associated with transplant across all ages and both genders, these important age and gender differences in mortality highlight the importance of attentive clinical management in younger children and girls and suggest the need for additional studies to explore the etiology of these differences in mortality risk. Furth et al. had raised concerns for differential access to the kidney transplant waiting list by racial background (16Furth SL Garg PP Neu AM et al.Racial differences in access to the kidney transplant waiting list for children and adolescents with end-stage renal disease..Pediatrics. 2000; 106: 756-761Crossref PubMed Scopus (127) Google Scholar). Raising further concern for racial differences in access to kidney transplantation, we observed that more African American subjects remained on the waiting list compared to Caucasian subjects, although there were no significant differences in mortality rates. We acknowledge the limitations of our study. Due to the observational nature of the data, it is possible that latent factors which occur differentially between transplanted and waitlisted patients may lead to bias in our association estimates. By selecting those pediatric patients that have been placed on the waitlist, it is likely that the overall health status is comparable for most patients due to the need to be an acceptable transplant candidate at the time of listing. We identified a potential for survivor treatment selection bias in this cohort (17Glesby MJ Hoover DR. Survivor treatment selection bias in observational studies: Examples from the AIDS literature..Ann Intern Med. 1996; 124: 999-1005Crossref PubMed Scopus (141) Google Scholar). Patients who live longer have more time and opportunities to decide or begin treatment; those who die earlier are untreated by default. Among the patients for this study, there was a higher mortality rate among those who were placed on the waiting list prior to or around the time of the initiation of dialysis therapy compared to subjects who were waitlisted after initiation of dialysis. Patients with CKD who have survived the transition to dialysis will have the opportunity for a kidney transplant compared to those who did not survive through the initiation of dialysis. Accounting for this potential bias in the multivariate analysis, the survival advantage associated with kidney transplant was still present. The findings of our study represent a highly selected population of pediatric patients who are placed on the waiting list for kidney transplant, as recorded by UNOS within the USRDS. Those subjects who underwent kidney transplantation without placement on the waiting list for kidney transplant were not included in this study. Data derived from the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) kidney transplant registry indicate that 52% of subjects received their allograft from a living donor (18NAPRTCS.NAPRTCS: 2007 Annual Report.. EMMES, Rockville, MD2007Google Scholar). The NAPRTCS is a source of data regarding the care and outcome of children undergoing ESRD therapy including kidney transplantation in North America, independent of UNOS. Demonstrating the selection bias for this analysis, approximately 30% subjects in our study received an allograft from a living related donor. Compared to kidney transplant subjects in the NAPRTCS, subjects in our study tended to be older (53% in the 13- to 18-year age group compared to 46.6% in the NAPRTCS ≤13 years); our study had more African Americans subjects (25.7% vs. 16.7% in the NAPRTCS), but gender distribution was similar (57% male vs. 59.3% male in the NAPRTCS) (18NAPRTCS.NAPRTCS: 2007 Annual Report.. EMMES, Rockville, MD2007Google Scholar). Despite the potential limitations in generalizing our findings to all pediatric patients undergoing kidney transplant evaluation, our findings are representative of the US pediatric population with CKD stage 5 who are placed on the kidney transplant waiting list. Other relevant data to use as adjustment factors in the multivariate analysis were not available or too incomplete to be useful. Nutritional markers associated with mortality in this patient population such as serum albumin and anthropometric measures such as growth and body mass index are not collected at the time of wait listing and hence were not available for use in our analysis. However, we were able to adjust for many of the primary demographic factors that have been associated with mortality in the ESRD population, including age, ethnicity and cause and duration of disease. Reliable information regarding subjects on the waiting list who were placed ‘on hold’ was not available and could not be assessed in our analysis. Finally, the lack of complete data collection on transplant-specific covariates such as HLA matching, donor-specific characteristics and immunosuppression regimens limits our ability to evaluate their contribution to the study’s findings. Kidney transplantation is considered the optimal treatment for children with chronic kidney failure. Our findings in a large population of pediatric patients who have been listed for kidney transplant in the United States demonstrate that those who receive a kidney allograft have an associated long-term survival advantage compared to their peers remaining on the kidney transplant waiting list. With the potential for unmeasured bias in this observational data and the limitations due to samples size, the results of the analysis should be interpreted conservatively. Furthermore, this study highlights the ongoing need for the pediatric renal registries and potential expansion of their data collection such that the long-term outcomes and the effects of medical interventions in the pediatric CKD population may be further characterized. Portions of this study were presented at the 39th annual meeting of the American Society of Nephrology, November 2006, San Diego, CA. The data reported here have been supplied by the United States Renal Data System. The interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official policy of or an interpretation by the US Government or Amgen. This work was funded by a Research Grant from the Department of Pediatrics, University of New Mexico School of Medicine." @default.
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