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

Pahari 1993.

Study characteristics
Methods
  • Study design: parallel, open‐label RCT

  • Study duration: before 1993

  • Duration of follow‐up: 46 ± 10.2 months

Participants
  • Setting: not reported

  • Country: India

  • Patients with biopsy‐proven IMN and > 2.0 g/24 hours proteinuria

  • Baseline characteristics

    • Proteinuria (g/24 hours): ≥ 2

    • SCr (mg/dL): ≤ 2

    • Baseline declining kidney function: no

  • Number (randomised/analysed): treatment group 1 (42/36); treatment group 2 (48/35)

  • Mean age ± SD (years): treatment group 1 (35 ± 16); treatment group 2 (32 ± 20)

  • Sex (M/F): treatment group 1 (25/11); treatment group 2 (24/11)

Interventions Treatment group 1
  • Prednisolone (oral): 4 mg/kg/day from 1 to 3 days followed by oral prednisolone 0.5 mg/kg/day from 4 to 30 days (Injection dexamethasone 1 mg/kg/day from 1 to 3 days in cases who are intolerant to high dose oral prednisolone)

  • CPA (oral): 2 mg/kg/day from 1 to 30 days of next months (oral chlorambucil was used in patients intolerant to oral CPA). The treatment was continued for 1 year


Treatment group 2
  • Prednisolone (oral): 60 mg/day was given for 12 weeks

Outcomes
  • Death

  • ESKD

  • 50% or 100% SCr increase

  • Partial or complete remission

  • Side effects leading to patient withdrawal or hospitalisation

Notes
  • Funding source: not reported

  • Drop‐out rate: treatment group 1 (6/42); treatment group 2 (13/48)

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 No sufficient detail 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 Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes High risk 90 patients were randomised, only 71/90 (79%) were finally analysed. The missing outcome data were not balanced in numbers across intervention groups: 6/42 (14%) in CPA group and 13/48 (27%) in prednisolone 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 The inclusion criteria of proteinuria was 2 g/24 hours rather than 3.5 g/24 hours