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. 2021 Nov 15;2021(11):CD004293. doi: 10.1002/14651858.CD004293.pub4

Cattran 1989.

Study characteristics
Methods

  • Study design: parallel, open‐label RCT

  • Study duration: 1977 to 1985

  • Duration of follow‐up: 48 ± 3.2 months. 72% of the 158 patients were followed for 3 years or more
Participants

  • Setting: single centre

  • Country: Canada

  • Inclusion criteria: biopsy‐proven IMN; 120/158 patients with IMN had nephrotic‐range proteinuria (64 in the prednisone group and 56 in the control group), while the remaining 38 patients did not have the diagnosis of nephrotic syndrome

  • Baseline characteristics

    • Pathology stage (I/II/III/IV): treatment group (6/33/33/9); control group (7/35/28/7)

    • Mean proteinuria ± SD (g/24 hours): treatment group (6.9 ± 0.8); control group (5.2 ± 0.9)

    • Hypertension: treatment group (28/81); control group (24/77)

    • Mean serum albumin ± SD (g/L): treatment group (27 ± 1.3); control group (30 ± 1)

    • Mean SCr ± SD (μmol/L): treatment group (120 ± 10); control group (103 ± 9)

    • Mean GFR ± SD (mL/sec/1.73 m²): treatment group (1.3 ± 0.08); control group (1.5 ± 0.08)

    • Baseline declining kidney function: a portion had declining kidney function

    • Previous immunosuppressive status: the use of any immunosuppressive agent other than prednisone was not allowed in the 6 months before entry

  • Number (randomised/analysed): treatment group (81/65); control group (77/55)

  • Median age, range (years): treatment group (46, 18 to 77); control group (45, 16 to 83)

  • Sex (M/F): treatment group (61/20); control group (44/33)

  • Exclusion criteria: positive renal venogram for thrombosis
Interventions Treatment group

  • Prednisone: 45 mg/m² in a single dose on alternate days for 6 months. The cumulative dose was 0.6 ± 0.05 mg/kg/day


Control group

  • No specific treatment for 6 months
Outcomes

  • Death

  • ESKD

  • Partial or complete remission

  • Side effects leading to patient withdrawal or hospitalisation
Notes

  • Baseline comparison: comparable

  • Funding information: supported by grants from the Kidney Foundation of Canada

  • Sample size calculation: the estimated total sample size was 150 patients; enrolled 158

  • Confounding factors: no
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were assigned by the study coordinator in Toronto Glomerulonephritis Registry according to a table of random numbers
Allocation concealment (selection bias) Low risk Central Randomisation method described could not allow investigators/participants to know or influence intervention group before eligible participant entered in the study
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk 27/158 (17%) patients were lost during follow‐up of 48 months: 10/81 (12%) in the prednisolone group and 17/77 (22%) in the control group
Selective reporting (reporting bias) Low risk The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were pre‐specified
Other bias High risk 158 patients were properly randomised, only 120 of them were diagnosed with nephrotic syndrome. The randomisation was not stratified according to nephrotic syndrome or non‐nephrotic syndrome