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

Dussol 2008.

Study characteristics
Methods

  • Study design: parallel, open‐label RCT

  • Study duration: January 2004 to January 2008

  • Duration of follow‐up: 12 months
Participants

  • Setting: multicentre

  • Country: France

  • Inclusion criteria: biopsy‐proven IMN and nephrotic syndrome

  • Baseline characteristics

    • Pathology stage (I/II): treatment group (8/9); control group (13/6)

    • Mean proteinuria ± SD (g/24 hours): treatment group (6.2 ± 3.5); control group (9.5 ± 5.8)

    • Mean serum albumin ± SD (g/L): treatment group (23.2 ± 7.3); control group (20.2 ± 6.0)

    • Mean SCr ± SD (mg/dL): treatment group (1.01 ± 0.34); control group (1.09 ± 0.39)

    • Mean GFR ± SD (mL/min/1.73 m²): treatment group (92.1 ± 29.8); control group (80.7 ± 25.4)

    • Baseline declining kidney function: initial Cr was < 200 μmol/L in all included patients

    • Use of ACEi or ARB during follow‐up: yes, no confounding effect. In the control group, 14 patients received ACEi, 1 received ARB, and 2 received a combination of ACEi and ARB In the MMF group, 17 patients received ACEi, 1 received ARB, and 1 received a combination of ACEi and ARB

    • Previous immunosuppressive status: no patient received previous immunosuppressive treatment before entry

  • Number (randomised/analysed): treatment group (19/15); control group (17/17)

  • Mean age ± SD (years): treatment group (47.8 ± 15.2); control group (55.9 ± 15.2)

  • Sex (M/F): treatment group (17/2); control group (15/2)

  • Exclusion criteria: secondary MGN regardless of the cause; diagnosis of MGN for more than 6 months; previously treated with an immunosuppressive agent
Interventions Treatment group

  • MMF: 250 mg/day, progressively increased by 250 mg every other day to 2 g/day for 12 months. MMF therapy was then progressively stopped in 15 days. Mean dose of MMF was 1,850 mg. Sixteen patients could achieve the target dose of 2 g/day. Two patients were maintained on 1.5 g/day, and 1 was maintained on 1 g/day because of gastrointestinal symptoms

  • Conservative treatment (as per control)


Control group

  • Conservative treatment

    • Renin‐angiotensin blockers, statins, low‐salt and low‐protein diet, and diuretics in case of oedema
Outcomes

  • Death

  • ESKD

  • 50% or 100% SCr increase

  • Final GFR

  • Partial or complete remission

  • Side effects leading to patient withdrawal or hospitalisation
Notes

  • Funding information: partial support for this study was provided by Roche through technical assistance and financing for the clinical research assistant. Roche did not intervene in the design or conduct of the study, analysis and interpretation of the data, or preparation of the article
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote "Randomization was performed by each centre through a centralized Internet on‐line application provided by the sponsor (minimization method). Randomization was stratified according to sex and centre"
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 No patients were lost 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 Low risk The study appeared to be free of other sources of bias