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. 2016 Oct 11;2016(10):CD003594. doi: 10.1002/14651858.CD003594.pub5
Methods
  • Study design: cross‐over RCT

  • Time frame: not reported

  • Follow‐up period: 20 weeks; first part of cross‐over included so outcome at 8 weeks used

Participants
  • Setting: tertiary centre

  • Country: India

  • SRNS (no remission after 8 weeks of prednisone); patients with initial SRNS (15) or late SRNS (10) following response to prednisone

  • Number (high dose/low dose): 14/11

  • Age (range)

    • High dose: 78 months (60 to 104.7)

    • Low dose: 96 months (80.5 to 136.4)

  • Sex (M/F)

    • High dose: 9/5

    • Low dose: 9/2

  • Histology

    • High dose: MCD (3); FSGS (5); MCGN (3); MesPGN (3)

    • Low dose: MCD (1); FSGS (4); MCGN (4)

  • Exclusion criteria: severe hypertension (SBP or DBP > 99th percentile); GFR < 70 mL/min/1.73 m2; secondary nephrotic syndrome (SLE, HSP, Hepatitis B, amyloidosis); single functioning kidney; treatment with daily prednisone, IV steroids, alkylating agents, levamisole, CSA, IV albumin in previous 4 weeks; patients unable to attend 4 weekly visits; age < 1 year or > 16 years

Interventions High dose enalapril
  • 0.6 mg/kg/d for 8 weeks in 2 doses


Low dose enalapril
  • 0.2 mg/kg/d for 8 weeks in 2 doses


Co‐interventions
  • Alternate day prednisone, frusemide

Outcomes
  • Urine albumin/Cr ratios (median, 95% CI) after 8 weeks

  • Urine albumin/Cr reduction (median, 95% CI) after 8 weeks

  • Levels of Cr, albumin, cholesterol, potassium, BP

  • Adverse events: cough

Notes
  • Exclusions post randomisation but pre‐intervention: 4 (high dose group (1), low dose group (3)) excluded after randomisation and before treatment

  • Stop or end points/s: not reported

  • Additional data requested from authors: Information on allocation concealment, study characteristics and results received from authors

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated random numbers
Allocation concealment (selection bias) Low risk Sealed opaque envelopes opened by investigator, who did not manage the patients (information from author)
Blinding of participants and personnel (performance bias) All outcomes High risk No blinding of participants or investigators; lack of blinding could influence management
Blinding of outcome assessment (detection bias) All outcomes Low risk Laboratory assessment of outcome unlikely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) All outcomes Low risk All patients randomised were included and completed the study (information from authors)
Selective reporting (reporting bias) High risk Outcomes reported (urinary albumin excretion, kidney function, adverse events) but no results could be included in meta‐analyses
Other bias Unclear risk Funding source not stated