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. 2008 Jul 16;2008(3):CD003233. doi: 10.1002/14651858.CD003233.pub2

Cattran 1999.

Methods Design: Placebo‐controlled RCT
Blinding: Single‐blind
Participants
  1. 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.

  2. Country: Canada/USA.

  3. Age: 18‐70 years.

  4. Number: Treatment group (26), control group (23).

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
  1. Number with CR: proteinuria ≤ 0.3 g/d + stable kidney function.

  2. Number with PR: 50% reduction of initial PU and ≤ 3.5 g/d with stable kidney function.

  3. Number with ESKD: CrCl < 12 mL/min, start of dialysis or transplantation or study closure.

Notes
  1. 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).

  2. 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.

  3. All patients were followed for an average of 200 weeks.

Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate