A RANDOMIZED TRIAL OF CYCLOSPORINE IN STEROID-RESISTANT IDIOPATHIC NEPHROTIC SYNDROME

To compare the efficacy (induction of remission) and safety of cyclosp orine (CsA) with those of supportive therapy in patients with steroid- resistant idiopathic nephrotic syndrome (INS), we organized an open, p rospective, randomized, multicentric, controlled study for parallel gr oups, stratified for adults and children. Forty-five patients with ste roid-resistant INS were randomly assigned to supportive therapy or CsA (5 mg/kg/day for adults, 6 mg/kg/day for children) for six months, th en tapered off by 25% every two months until complete discontinuation. Four patients were lost to follow-up. During the first year 13/22 CsA -treated patients versus three of 19 controls attained remission of th e nephrotic syndrome (P < 0.001). A symptom score was assessed at time 0 and at six months. The mean score significantly decreased in the Cs A group (P < 0.001), but remained unchanged in the controls. At month 6 the mean urinary protein excretion, the mean serum proteins and plas ma cholesterol had significantly improved in the CsA group but were no t changed in the controls. There were no significant differences in se rum creatinine and creatinine clearance between treatments (interactio n time treatments, P = 0.089 and P = 0.935, respectively) at month 6 versus basal. The CsA-related side-effects were mild; no significant d ifference in blood pressure between the two groups was seen at any tim e. This study shows that CsA can bring about remission in some 60% of patients with steroid-resistant INS. In patients with normal renal fun ction and without severe hypertension, CsA at the therapeutic scheme a dopted did not produce severe renal or extrarenal toxicity.