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

Tiller 1981.

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

  • Study duration: May 1974 to November 1980

  • Duration of follow‐up: 36 months

Participants
  • Setting: multicentre

  • Country: Australia

  • Inclusion criteria: biopsy‐proven IMN

  • Baseline characteristics

    • Pathology stage: not reported

    • SCr: patients with SCr < 350 μmol/L

    • GFR: patients with GFR ≥ 0.33 mL/sec/1.73 m² (20 mL/min/1.73 m²)

    • Baseline declining kidney function: no

    • Use of ACEi or ARB during follow‐up: not reported

    • Previous immunosuppressive status: previous treatment did not preclude patients from the study, provided that they had been on no "specific" treatment for a period of 6 months before entering the study

  • Number: treatment group (27); control group (27)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • CPA: 1.5 mg/kg/day for 6 mouths

  • Dipyridamole and sodium warfarin therapy were prescribed

  • Symptomatic treatment


Control group
  • Symptomatic treatment

Outcomes
  • Death

  • ESKD

  • Side effects leading to patient withdrawal or hospitalisation

Notes
  • Funding source: supported by a grant from the National Health and Medical Research Council of Australia

  • The full text was published at a conference

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 29/54 patients (54%) completed the 36‐month follow‐up: 14/27 (52%) in the treatment group and 15/27 (56%) in the control group. The missing numbers of patients were balanced and the missing reason was specified in each patient. The rate of loss to follow‐up was high (54%), intention‐to‐treat principle was used to deal with these data to avoid potential bias
Selective reporting (reporting bias) Low risk The primary outcomes and key adverse effects were detailed in the publication, although other outcomes were not available to be included in this meta‐analysis
Other bias Unclear risk Insufficient information to permit judgement