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

Agarwal 2012a.

Study characteristics
Methods

  • Study design: parallel, open‐label RCT

  • Study duration: not reported

  • Follow‐up period: primary endpoint at 6 months and secondary endpoint at 12 months
Participants

  • Setting: single centre

  • Country: India

  • Inclusion criteria: IMN; nephrotic syndrome despite adequate treatment with telmisartan; eGFR > 30 mL/min

  • Baseline characteristics

    • Mean duration of oedema: 8 months

    • Pathological classification (I/II/III/IV): treatment group (0/18/2/0), control group (0/21/0/0)

  • Number: treatment group (20), control group (21)

  • Mean age: 38 years

  • Sex (M/F): 34/7

  • Exclusion criteria: not reported
Interventions Treatment group

  • TAC (oral): 0.1 mg/kg/day for 6 months then tapered off over 6 months

  • Prednisolone: 0.5 mg/kg/day, until remission then tapered by 5 mg/week with a minimal maintenance dose


Control group

  • Modified Ponticelli Regimen

    • CPA + prednisolone for 6 months
Outcomes

  • Complete or partial remission at 6 months

  • Partial remission

  • Any remission

  • Kidney survival
Notes

  • Abstract‐only publication

  • Funding source: not reported

  • Declarations of Interests/disclosures: not reported

  • The author kindly provided further details (baseline characteristics and treatment arm sizes) upon request

  • Ethics: the protocol was ethically approved; an informed consent form was obtained from each participant

  • Trial registration or protocol registration or publication: Clinical Trial Registry of India (CTRI/2010/091/000231)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
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 Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) Low risk Primary and secondary endpoints comprehensively reported; trial registered at clinical trial registry
Other bias Unclear risk Incomplete reporting. No financial disclosures provided