| Study characteristics |
| Methods |
Study design: parallel, open‐label RCT Study duration: 1995 to 2002 Duration of follow‐up: at least 36 months |
| Participants |
Setting: single centre Country: Serbia Inclusion criteria: biopsy‐proven high‐risk IMN; all had nephrotic syndrome with average proteinuria of 9 g/day -
Baseline characteristics
Pathology stage (I/II/III/IV): treatment group 1 (mean 2.2); treatment group 2 (mean 2.08) Mean proteinuria ± SD (g/24 hours): treatment group 1 (11.6 ± 4.7); treatment group 2 (7.0 ± 2.7) Mean serum albumin ± SD (g/L): treatment group 1 (22.9 ± 4.8); treatment group 2 (28.3 ± 6.4) Mean SCr ± SD (μmol/L): treatment group 1 (124.5 ± 75.9); treatment group 2 (120.5 ± 46.5) Mean GFR ± SD (mL/min): treatment group 1 (80.7±27.5); treatment group 2 (76.2 ± 31.3) Baseline declining kidney function: 22% of the patients exhibited elevated SCr values, and nearly 40% had lower CrCl Use of ACEi or ARB during follow‐up: yes, no confounding effect. ACEi were also given to all patients either in doses needed for adequate regulation of arterial hypertension or in normotensive patients in smaller amounts to achieve an antiproteinuric effect. During the 3‐year follow‐up, newly diagnosed hypertension was recorded in two patients in the CSA group that required an increased dose of ACEi or addition of another antihypertensive. Hypertension developed in three new patients of AZA was successfully regulated by ACEi and calcium channel antagonists Previous immunosuppressive status: all the patients previously received chlorambucil and corticosteroids for 6 months. The lead‐time between the end of this treatment and the beginning of the new treatment was at least 1 year: treatment group 1 (17.9 ± 4.9 months); treatment group 2 (19.5 ± 8.1 months)
Number: treatment group 1 (10); treatment group 2 (13) Mean age ± SD (years): treatment group 1 (39.2 ± 13.1); treatment group 2 (47.5 ± 8.2) Sex (M/F): treatment group 1 (9/1); treatment group 2 (10/3) Exclusion criteria: not reported |
| Interventions |
Treatment group 1
CSA: 3 mg/kg/day. During follow‐up, the CSA dose was adjusted to achieve 12‐hour trough levels of 80 to 100 ng/mL Prednisone: 0.5 mg/kg/day for 8 weeks. The dose was gradually reduced to 5 to 10 mg/day and remained unchanged until the end of the treatment. CSA and prednisone were slowly discontinued over 2 weeks at the end of the 24‐month period
Treatment group 2
AZA: 1.5 to 2 mg/kg for 6 months, and afterwards 50 mg/day. AZA was temporarily withdrawn, or the dose was reduced if the WCC fell below 4 x 109/L Prednisone: 0.5 mg/kg/day for 8 weeks. The dose was gradually reduced to 5 to 10 mg/day and remained unchanged until the end of the treatment AZA and prednisone were slowly discontinued over 2 weeks at the end of the 24‐month period
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| Outcomes |
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| Notes |
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information about the sequence generation process to permit judgement |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information about concealment of the random allocation sequence before or during enrolment of participants |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All patients completed the study and there were no losses to follow‐up |
| 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 |
This study was not fully randomised |
