Methods |
Design: Placebo‐controlled RCT Blinding: Single‐blind |
Participants |
Inclusion criteria: Biopsy‐proven FSGS, proteinuria ≥ 3.5 g/d or ≥ 50 mg/kg, CrCl ≥ 42 mL/min/1.73 m², BP ≤ 135/90 mm Hg, dietary protein intake ≤ 0.8 g/kg.
Country: Canada/USA.
Age: 18‐70 years.
Number: Treatment group (26), control group (23).
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Interventions |
Treatment group
CSA 3.5 mg/kg/d in 2 divided doses and low‐dose prednisone at 0.15 mg/kg/d (maximum daily dose 15mg). Control group
Placebo in 2 divided doses and prednisone at 0.15 mg/kg/d (maximum daily dose of 15 mg).
Duration: 26 weeks, then tapered. |
Outcomes |
Number with CR: proteinuria ≤ 0.3 g/d + stable kidney function.
Number with PR: 50% reduction of initial PU and ≤ 3.5 g/d with stable kidney function.
Number with ESKD: CrCl < 12 mL/min, start of dialysis or transplantation or study closure.
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Notes |
Prior to therapy both, placebo and treatment group received prednisone for a mean duration of 13 weeks (treatment group, mean dose 120 mg/kg) and 14 weeks (control group, mean dose 100 mg/kg).
11 patients (control group (5), treatment group (6)) received a course of a cytotoxic agent (cyclophosphamide (9), azathioprine (2)) in a dose range of 1‐3 mg/kg for a mean of 2 months.
All patients were followed for an average of 200 weeks.
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |