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. 2020 Jan 13;2020(1):CD003232. doi: 10.1002/14651858.CD003232.pub4

Rifle 1980.

Methods

  • Study design: parallel RCT

  • Duration of study: October 1977 to March 1981

  • Duration of follow‐up: 4 to 45 months
Participants

  • Country: France

  • Setting: multicentre

  • Inclusion criteria: new onset RPGN with > 50% glomerular crescents

  • Number: treatment group (6); control group (8)

  • Mean age, range (years): treatment group (40.7, 9 to 75); control group (52.1, 37 to 66)

  • Sex (M/F): treatment group (3/3); control group (2/6)

  • HD at start: treatment group (4/6); control group (7/8)

  • Exclusion criteria: Goodpasture's syndrome; IgA nephropathies; SLE; systemic disease
Interventions Treatment group

  • Immunosuppression as per control group

  • PE: 5 sessions during 5 successive days, then 3 sessions/week until 15 days after SCr reached a plateau

    • Treatment could not exceed 2 months

    • 150% plasma volume was exchanged for albumin and saline solution at each session


Control group

  • Immunosuppression

    • IV pulse MP: 15 mg/kg/day for 3 days, tapered to 15 mg/day for 3 days, then 3 new pulses, then 15 mg/day for 7 weeks

  • CPA: 2 to 3 mg/kg/day for 2 months

  • Calcium heparinate 9 days after kidney biopsy for the duration of the study
Outcomes

  • Dialysis: 2, 6 12, 24 months

  • CrCl: 2, 6 and 12 months

  • Recovery (off dialysis) according to initial SCr level

  • Recovery (off dialysis) according to initial % of crescents

  • Death

  • Circulating immune complexes

  • Pathology changes

  • Adverse events (septicaemia)
Notes

  • End point: treatment was stopped after 1 month in both groups if no improvement occurred

  • Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "patients were divided into 2 groups"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unable to blind participants or personnel; unlikely to affect outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unable to determine numbers randomised and if all were analysed
Selective reporting (reporting bias) Low risk Study and review outcomes reported
Other bias Unclear risk Funding source not reported