| Methods |
Design: Open prospective RCT |
| Participants |
Inclusion criteria: Adults with biopsy‐proven FSGS, nephrotic syndrome and CrCl > 80 mL/min/1.73 m². Country: Italy Age: 20.1‐ 57.7 years. Number: Treatment group (10), control group (9). |
| Interventions |
Treatment group
CSA orally at the initial dose of 5 mg/kg/d divided in 2 doses. After sixth months CSA was stopped in those who had not obtained either complete or partial remission. For those who responded the dose was reduced by 25% every 2 months, so that CSA was stopped by the end of one year. CrCl: 99.89 ± 35.99 mL/min/1.73 m². Proteinuria: 167.15 ± 55.84 mg/m²/h.
Control group
Supportive treatment only, (excluding corticosteroid and immunosuppressive agents), erythromycin, cotrimoxazole, aminoglycosides, ACEi, NSAIDs, and/or anti‐epileptic drugs. Duration: For non‐responders 6 months and for responders 6 months then tapered off until end of year. CrCl: 99.42 ± 29.36 mL/min/1.73 m². Proteinuria: 196.16 ± 159.66 mg/m²/h.
|
| Outcomes |
Number with CR: Proteinuria ≤ 0.2 g/d on 3 non‐consecutive days. Number with PR: Proteinuria ≤ 3.5 g/d on 3 non‐consecutive days. Number with relapse of nephrotic syndrome: Patients who attained CR or PR but with the reappearance of proteinuria > 3.5 g/d for at least 2 weeks. |
| Notes |
Median duration of follow‐up: 18 months (3‐24) for treatment group and 24 months (12‐24) for control group. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
