A CONTROLLED TRIAL OF CYCLOSPORINE IN PATIENTS WITH PROGRESSIVE MEMBRANOUS NEPHROPATHY

A controlled trial of cyclosporine in patients diagnosed with progress ive membranous nephropathy (MGN) was carried out to determine whether cyclosporine (D) would be more effective than placebo (P) in reducing the rate of deterioration in renal function. Patients (N = 64) with MG N were placed on a restricted protein diet (less than or equal to 0.9 g/kg) and followed closely for 12 months (Part 1). Patients at high ri sk of progression based on an absolute loss in creatinine clearance (C -Cr) of greater than or equal to 8 ml/min and persistent nephrotic ran ge proteinuria (Pr) were selected and randomly assigned to either (D) (N = 9) or (P) (N = 8) for 12 months (Part 2). No differences in the t wo groups were noted at entry. After 12 months, the improvement in C-C r slope in ml/min/month was significantly greater in the D patients (D + 2.1 vs. P + 0.5, mean difference 1.6; 95% CI 0.3 to 3.0, P < 0.02). This improvement was maintained in six of eight D (75%) over a mean f ollow-up period of 21 months. Daily Pr also improved with D (by month 3, D - 4.5 g/day vs. P + 0.7 g/day, P = 0.02) and was sustained in six of eight (75%) D patients. When Pr was expressed as a function of the ir concurrent C-Cr, the D versus P patients' time to halving was faste r (P = 0.02) and absolute number higher (4/9 D vs 0/8 P). In the D gro up a trend towards worse hypertension and an increase in the number of transient rises in serum creatinine were noted. In progressive MGN, D is often effective in reducing both the rate of renal deterioration a nd Pr. These benefits extended for up to two years post-treatment.