FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4225665220> ?p ?o ?g. }

• W4225665220 endingPage "129" @default.
• W4225665220 startingPage "119" @default.
• W4225665220 abstract "Anemia caused by iron depletion is common in patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD-5HD) patients. To maintain the iron levels, external administration of iron is essential. Ferric pyrophosphate citrate (FPC) is a novel, water-soluble complex iron salt. The present study was conducted to evaluate the pharmacokinetic (PK) parameters and safety of FPC in adult healthy Chinese subjects and patients with CKD-5HD. Two open-label, single-center studies were conducted in healthy subjects and patients with CKD-5HD. Healthy subjects received a single intravenous dose of 6.5 mg FPC solution, while CKD-5HD patients were randomized to two different sequences of FPC administration at two sequential hemodialysis (HD) treatments (dose 1 and dose 2). Patients received 27.2 mg of FPC at a dialysate concentration of 95 μg/L for 4 h or a single 6.5 mg dose of FPC administered intravenously via the pre-dialyzer blood circuit. The primary objective was to determine the PK parameters of total serum iron (Fetot), while the secondary objective was the safety of the FPC solution. PK parameters were calculated using Phoenix WinNonlin 8.1 and other parameters were analyzed using SAS 9.4 software. Comparison between HD dose 2 and HD dose 1 was performed using the Wilcoxon rank-sum test and analysis of variance (ANOVA). A total of 14 healthy subjects with a mean age of 30.8 ± 5.92 years and 12 HD patients with a mean age of 54.3 ± 16.47 years were included. In healthy subjects, the peak serum concentration was reached at the end of infusion of FPC, with an adjusted mean maximum concentration (Cmax,) of 33.46 ± 4.83 μmol/L at a mean time to reach Cmax (Tmax) of 4.09 ± 0.19 h. In patients with CKD-5HD, the adjusted mean Cmax of HD dose 2 was 25.37 ± 4.30 μmol/L at a Tmax, of 3.09 ± 0.32 h, whereas the Cmax, of HD dose 1 was 24.59 ± 4.77 μmol/L at a Tmax, of 3.96 ± 0.26 h. The Fetot concentration-time curves were observed to be similar for both administration methods (HD doses 1 and 2), while the PK parameters differed significantly for Tmax (p = 0.001; baseline correction) and area under the concentration-time curve from time zero to time t (AUCt) [p = 0.031 for cycle variance; without baseline correction] between HD doses 1 and 2. The geometric mean ratios (HD dose 1/HD dose 2) for Cmax and AUCt were within the 85–125% range (Cmax 96.56%; AUCt 96.07%). A total of three and two incidences of adverse events were reported in healthy subjects and patients with CKD-5HD, respectively. FPC showed a good PK and safety profile and hence can be used as maintenance therapy for patients with CKD-5HD by choosing a better method of administration based on clinical feasibility and requirement. CTR20181113 and CTR20181119." @default.
• W4225665220 created "2022-05-05" @default.
• W4225665220 creator A5008017308 @default.
• W4225665220 creator A5020235139 @default.
• W4225665220 creator A5026189241 @default.
• W4225665220 creator A5047657819 @default.
• W4225665220 creator A5050179474 @default.
• W4225665220 creator A5059274455 @default.
• W4225665220 creator A5066354708 @default.
• W4225665220 creator A5066927654 @default.
• W4225665220 creator A5069331466 @default.
• W4225665220 creator A5077679832 @default.
• W4225665220 creator A5084263453 @default.
• W4225665220 creator A5086764085 @default.
• W4225665220 date "2022-04-05" @default.
• W4225665220 modified "2023-10-18" @default.
• W4225665220 title "Pharmacokinetics and Safety of Ferric Pyrophosphate Citrate in Chinese Subjects with and without Hemodialysis-Dependent Stage 5 Chronic Kidney Disease" @default.
• W4225665220 cites W1560264875 @default.
• W4225665220 cites W2018753403 @default.
• W4225665220 cites W2062616926 @default.
• W4225665220 cites W2109305563 @default.
• W4225665220 cites W2110622197 @default.
• W4225665220 cites W2111528788 @default.
• W4225665220 cites W2147671904 @default.
• W4225665220 cites W2179278454 @default.
• W4225665220 cites W2403466586 @default.
• W4225665220 cites W2509762573 @default.
• W4225665220 cites W2588704031 @default.
• W4225665220 cites W2604904897 @default.
• W4225665220 cites W2772547249 @default.
• W4225665220 cites W2811977561 @default.
• W4225665220 cites W2916485824 @default.
• W4225665220 cites W2938968314 @default.
• W4225665220 cites W3118845665 @default.
• W4225665220 cites W3147940220 @default.
• W4225665220 doi "https://doi.org/10.1007/s40268-022-00384-5" @default.
• W4225665220 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/35380419" @default.
• W4225665220 hasPublicationYear "2022" @default.
• W4225665220 type Work @default.
• W4225665220 citedByCount "0" @default.
• W4225665220 crossrefType "journal-article" @default.
• W4225665220 hasAuthorship W4225665220A5008017308 @default.
• W4225665220 hasAuthorship W4225665220A5020235139 @default.
• W4225665220 hasAuthorship W4225665220A5026189241 @default.
• W4225665220 hasAuthorship W4225665220A5047657819 @default.
• W4225665220 hasAuthorship W4225665220A5050179474 @default.
• W4225665220 hasAuthorship W4225665220A5059274455 @default.
• W4225665220 hasAuthorship W4225665220A5066354708 @default.
• W4225665220 hasAuthorship W4225665220A5066927654 @default.
• W4225665220 hasAuthorship W4225665220A5069331466 @default.
• W4225665220 hasAuthorship W4225665220A5077679832 @default.
• W4225665220 hasAuthorship W4225665220A5084263453 @default.
• W4225665220 hasAuthorship W4225665220A5086764085 @default.
• W4225665220 hasBestOaLocation W42256652201 @default.
• W4225665220 hasConcept C112705442 @default.
• W4225665220 hasConcept C126322002 @default.
• W4225665220 hasConcept C126894567 @default.
• W4225665220 hasConcept C2778063415 @default.
• W4225665220 hasConcept C2778653478 @default.
• W4225665220 hasConcept C3019040382 @default.
• W4225665220 hasConcept C71924100 @default.
• W4225665220 hasConcept C90924648 @default.
• W4225665220 hasConceptScore W4225665220C112705442 @default.
• W4225665220 hasConceptScore W4225665220C126322002 @default.
• W4225665220 hasConceptScore W4225665220C126894567 @default.
• W4225665220 hasConceptScore W4225665220C2778063415 @default.
• W4225665220 hasConceptScore W4225665220C2778653478 @default.
• W4225665220 hasConceptScore W4225665220C3019040382 @default.
• W4225665220 hasConceptScore W4225665220C71924100 @default.
• W4225665220 hasConceptScore W4225665220C90924648 @default.
• W4225665220 hasIssue "2" @default.
• W4225665220 hasLocation W42256652201 @default.
• W4225665220 hasLocation W42256652202 @default.
• W4225665220 hasLocation W42256652203 @default.
• W4225665220 hasOpenAccess W4225665220 @default.
• W4225665220 hasPrimaryLocation W42256652201 @default.
• W4225665220 hasRelatedWork W1999890744 @default.
• W4225665220 hasRelatedWork W2025499134 @default.
• W4225665220 hasRelatedWork W2063122013 @default.
• W4225665220 hasRelatedWork W2065026575 @default.
• W4225665220 hasRelatedWork W2066161543 @default.
• W4225665220 hasRelatedWork W2149162188 @default.
• W4225665220 hasRelatedWork W2374153524 @default.
• W4225665220 hasRelatedWork W2746183029 @default.
• W4225665220 hasRelatedWork W4220816320 @default.
• W4225665220 hasRelatedWork W4226471102 @default.
• W4225665220 hasVolume "22" @default.
• W4225665220 isParatext "false" @default.
• W4225665220 isRetracted "false" @default.
• W4225665220 workType "article" @default.