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. 2019 Nov 21;2019(11):CD003594. doi: 10.1002/14651858.CD003594.pub6

Bhaumik 2002.

Methods
  • Study design: parallel group RCT

  • Time frame: January 1996 to March 2000

  • Follow up period: 6 months

Participants
  • Setting: Tertiary centre

  • Country: India

  • SRNS (biopsy proven primary FSGS); no response to 8 weeks of prednisolone (2 mg/kg/d)

  • Number (group A/group B): 13/12

  • Age range: 3 to 49 years

  • Sex (M/F): not reported but stated similar between groups

  • Exclusion criteria: SSNS

Interventions Group A
  • Cyclosporin 1 to 4 mg/kg/day with oral prednisolone for at least 6 months


Group B
  • Methylprednisolone 250‐750 mg IV daily for 7 days and then weekly for at least 12 weeks


Co‐interventions
  • BP control

  • Dietary protein 0.8 to 1.0 g/kg/d

  • ACE inhibitors

  • Lipid lowering agents

Outcomes
  • Complete remission

  • Decline in proteinuria & stable creatinine

  • Progression to ESKD

  • Rate of decline in GFR

  • Hospitalisation for therapy related complications

Notes
  • Abstract‐only publication

  • Funding source not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study described as randomised; method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided on how outcome was measured
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants accounted for
Selective reporting (reporting bias) Unclear risk Abstract‐only publication
Other bias Unclear risk Insufficient information to permit judgement