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- W1966658518 abstract "To the Editor: We wish to raise several issues regarding the publication by Maes et al1Maes B.D. Oyen R. Claes K. et al.Mycophenolate mofetil in IgA nephropathy: Results of a 3-year prospective placebo-controlled randomised study.Kidney Int. 2004; 65: 1842-1849Abstract Full Text Full Text PDF PubMed Scopus (200) Google Scholar, reporting on the effectiveness of mycophenolate mofetil (MMF) in IgA nephropathy (IgAN): (1) A sample of 34 patients is too little. We have started a randomized trial, ramipril versus ramipril plus MMF in IgAN2The Angiotensin Inhibition Mycophenolate Mofetil Iga Nephropathy Study Investigators. One-year angiotensin-converting enzyme inhibition plus mycophenolate mofetil immunosuppression in the course of early IgA nephropathy: A multicentre, randomised, controlled study. J NephrolsubmittedGoogle Scholar: 57 patients per group are required to maintain a power of 80% and a type error of 5%. For a dropout rate of 10%, a total sample size of 126 patients needs to be enrolled. In the placebo group, 2 patients (1 death, 1 adverse event) out of 13 patients (15%), and in the MMF group, 8 patients [2 end-stage renal disease (ESRD), 2 emigrated, 1 adverse event, 1 tuberculosis (TB), 2 gastrointestinal (GI) problems] out of 21 patients (38%) reduced or stopped the treatment before the end of the trial. (2) Inclusion criteria. “Eligible patients were randomized (2:1; MMF:placebo).” In a randomized trial all patients should have the same probability of receiving one or the other of the treatments being compared3Sackett D.L. Haynes R.B. Guyatt G.H. Tugwell P. Clinical Epidemiology. Lippincott Williams & Wilkins, Philadelphia, PA1991: 196Google Scholar. Renal function for inclusion was taken at the time of diagnosis (ie, 0 to 5 years back from randomization). Were patients with glomerular filtration rate (GFR) <20 mL/min included? Options for eligibility were also hypertension, proteinuria, and histologic severity, alone or in combination. Were these risk factors evenly distributed between groups? (3) A wash-out period for patients assuming enalapril was not performed, biasing proteinuria at entry. (4) In a small patient sample, data distribution is not usually normal and a nonparametric approach would have been more appropriate." @default.
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- W1966658518 date "2004-10-01" @default.
- W1966658518 modified "2023-09-27" @default.
- W1966658518 title "Mycophenolate mofetil in IgA nephropathy" @default.
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- W1966658518 doi "https://doi.org/10.1111/j.1523-1755.2004.938_5.x" @default.
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