Mycophenolate mofetil in IgA nephropathy: results of a 3-year prospective placebo-controlled randomized study.
BACKGROUND
Because humoral immunity is believed to play a pivotal role in the pathogenesis of IgA nephropathy (IgAN), a prospective placebo-controlled randomized study was started in patients with IgAN using mycophenolate mofetil (MMF).


METHODS
A total of 34 patients with IgAN were treated with salt intake restriction, angiotensin-converting enzyme (ACE) inhibition and MMF 2 g per day (N= 21) or placebo (N= 13). After 36 months of follow-up clinical, biochemical, and radiologic data were analyzed using linear mixed models for longitudinal data and Kaplan-Meier survival analysis.


RESULTS
Therapy had to be stopped prematurely in five patients. Two patients (MMF group) evolved to end-stage renal disease (ESRD). There was no difference between groups in the percentage of patients with a decrease of 25% or more in the inulin clearance or with a serum creatinine increase of 50% or more over 3 years. There was also no significant difference between groups in annualized rate of change of serum creatinine, computed by linear regression analysis. No significant difference was noted between groups for inulin clearance, serum creatinine, proteinuria, blood pressure, or other parameters of renal function. Hemoglobin and C-reactive protein were significantly lower in the MMF group compared with the placebo group. As a function of time, a significant decline in both groups was noted of proteinuria, parenchymal thickness of the kidneys and C3d.


CONCLUSIONS
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.
Maes
Bart D
BD
Department of Medicine, Division of Nephrology, University Hospital Gasthuisberg, Leuven, Belgium. bart.maes@uz.kuleuven.ac.be
Oyen
Raymond
R
Claes
Kathleen
K
Evenepoel
Pieter
P
Kuypers
Dirk
D
Vanwalleghem
Johan
J
Van Damme
Boudewijn
B
Vanrenterghem
Yves F Ch
YF
D000328:Adult; D000959:Antihypertensive Agents / Q000627:therapeutic use; D003404:Creatinine / Q000097:blood; D005260:Female; D005922:Glomerulonephritis, IGA / Q000150:complications / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D006801:Humans; D006977:Hypertension, Renal / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007668:Kidney / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011446:Prospective Studies
D000959:Antihypertensive Agents; D007166:Immunosuppressive Agents; D003404:Creatinine; D009173:Mycophenolic Acid