Mycophenolate mofetil in IgA nephropathy: Results of a 3-year prospective placebo-controlled randomized study

Maes, Bart; Oyen, Raymond; Claes, Kathleen; Evenepoel, Pieter; Kuypers, Dirk; Vanwalleghem, J; Damme, Boudewijn Van; Vanrenterghem, Yves

doi:10.1111/j.1523-1755.2004.00588.x

Cited by 218 publications

(165 citation statements)

References 28 publications

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“…However in this study BP control was well above currently accepted goals, and the use of RAS blockade was not reported [4]. Other recent RCTs of immune modulating therapy have used supportive therapy as 'standard of care' including three small studies of mycophenolate; among these trials, one, conducted in a Chinese population, indicated benefit [10] while two others, both in European populations, did not [11,12].…”

Section: What Does This Important Study Show?mentioning

confidence: 73%

Should Immunosuppressive Therapy Be Used in Slowly Progressive IgA Nephropathy?

Feehally

Barratt

2016

American Journal of Kidney Diseases

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Section: What Does This Important Study Show?mentioning

confidence: 73%

Should Immunosuppressive Therapy Be Used in Slowly Progressive IgA Nephropathy?

Feehally

Barratt

2016

American Journal of Kidney Diseases

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“…To date only four RCTs have compared MMF with placebo [4][5][6][7]11] and results have been conflicting. All studies have been small (between 17 and 22 patients receiving MMF monotherapy) and have utilised different inclusion criteria, ethnic populations and durations of follow up.…”

Section: Discussionmentioning

confidence: 99%

“…All studies have been small (between 17 and 22 patients receiving MMF monotherapy) and have utilised different inclusion criteria, ethnic populations and durations of follow up. Early studies from Belgium [4] and North America [5,7] showed no benefit from MMF therapy in treating IgAN. In contrast, Tang and colleagues found MMF significantly increased the likelihood of remission from proteinuria in a cohort of Chinese patients and lowered the risk of progression to end stage kidney disease compared to RAAS alone [6,11].…”

Section: Discussionmentioning

confidence: 99%

“…Current research has produced conflicting data about the benefit of mycophenolate mofetil (MMF) therapy in IgAN [4][5][6][7][8][9][10]. Four small randomised controlled trials have been performed, with a range of results reported.…”

Section: Introductionmentioning

confidence: 99%

“…Four small randomised controlled trials have been performed, with a range of results reported. Some have demonstrated no benefit from MMF therapy [4,5,7], particularly in advanced fibrotic disease [5], while others have described a reduction in proteinuria and long term renoprotection following treatment with MMF [6,11]. Previous studies looking at outcomes in IgAN have been limited by a lack of specific histological inclusion and exclusion criteria.…”

Section: Introductionmentioning

confidence: 99%

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Mycophenolate mofetil therapy in immunoglobulin A nephropathy: histological changes after treatment

Beckwith

Medjeral-Thomas

Galliford

et al. 2017

Nephrology Dialysis Transplantation

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Evaluating a New International Risk-Prediction Tool in IgA Nephropathy

et al. 2019

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IMPORTANCE Although IgA nephropathy (IgAN) is the most common glomerulonephritis in the world, there is no validated tool to predict disease progression. This limits patient-specific risk stratification and treatment decisions, clinical trial recruitment, and biomarker validation. OBJECTIVE To derive and externally validate a prediction model for disease progression in IgAN that can be applied at the time of kidney biopsy in multiple ethnic groups worldwide. DESIGN, SETTING, AND PARTICIPANTS We derived and externally validated a prediction model using clinical and histologic risk factors that are readily available in clinical practice. Large, multi-ethnic cohorts of adults with biopsy-proven IgAN were included from Europe, North America, China, and Japan. MAIN OUTCOMES AND MEASURES Cox proportional hazards models were used to analyze the risk of a 50% decline in estimated glomerular filtration rate (eGFR) or end-stage kidney disease, and were evaluated using the R 2 D measure, Akaike information criterion (AIC), C statistic, continuous net reclassification improvement (NRI), integrated discrimination improvement (IDI), and calibration plots. RESULTS The study included 3927 patients; mean age, 35.4 (interquartile range, 28.0-45.4) years; and 2173 (55.3%) were men. The following prediction models were created in a derivation cohort of 2781 patients: a clinical model that included eGFR, blood pressure, and proteinuria at biopsy; and 2 full models that also contained the MEST histologic score, age, medication use, and either racial/ethnic characteristics (white, Japanese, or Chinese) or no racial/ethnic characteristics, to allow application in other ethnic groups. Compared with the clinical model, the full models with and without race/ethnicity had better R 2 D (26.3% and 25.3%, respectively, vs 20.3%) and AIC (6338 and 6379, respectively, vs 6485), significant increases in C statistic from 0.78 to 0.82 and 0.81, respectively (ΔC, 0.04; 95% CI, 0.03-0.04 and ΔC, 0.03; 95% CI, 0.02-0.03, respectively), and significant improvement in reclassification as assessed by the NRI (0.18; 95% CI, 0.07-0.29 and 0.51; 95% CI, 0.39-0.62, respectively) and IDI (0.07; 95% CI, 0.06-0.08 and 0.06; 95% CI, 0.05-0.06, respectively). External validation was performed in a cohort of 1146 patients. For both full models, the C statistics (0.82; 95% CI, 0.81-0.83 with race/ethnicity; 0.81; 95% CI, 0.80-0.82 without race/ethnicity) and R 2 D (both 35.3%) were similar or better than in the validation cohort, with excellent calibration. CONCLUSIONS AND RELEVANCE In this study, the 2 full prediction models were shown to be accurate and validated methods for predicting disease progression and patient risk stratification in IgAN in multi-ethnic cohorts, with additional applications to clinical trial design and biomarker research.

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Mycophenolate mofetil in IgA nephropathy: Results of a 3-year prospective placebo-controlled randomized study

Abstract: In patients with IgAN at risk for progressive disease, no beneficial effect of 3-year treatment with MMF 2 g per day could be demonstrated on renal function/outcome or proteinuria. However, larger randomized studies are needed to confirm or reject these results.

Cited by 218 publications

References 28 publications

Should Immunosuppressive Therapy Be Used in Slowly Progressive IgA Nephropathy?

Should Immunosuppressive Therapy Be Used in Slowly Progressive IgA Nephropathy?

Mycophenolate mofetil therapy in immunoglobulin A nephropathy: histological changes after treatment

Evaluating a New International Risk-Prediction Tool in IgA Nephropathy

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