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

Zauner 2002.

Methods
  • Study design: parallel RCT

  • Duration of study: commenced 1986

  • Duration of follow‐up: 10 years

Participants
  • Country: Germany

  • Setting: multicentre

  • Inclusion criteria: clinical picture of biopsy‐proven RPGN and Couser Type II or III (immune deposits or pauci‐immune respectively)

  • Number: treatment group (21); control group (18)

  • Mean age: 52.3 years

  • Sex (M/F): 25/14

  • Exclusion criteria: Couser Type I GN (linear GBM Ab staining on biopsy); previous immunosuppression or PE

Interventions Treatment group
  • Immunosuppression as for control group

  • PE: 40 mL/kg with FFP replacement daily for 3 exchanges, continued if no response to a maximum of 12 exchanges; mean number of PE = 6


Control group
  • IV MP: 500 mg/day for 3 days. Prednisolone 80, 60 then 40 mg/day for a week each. Dose tapered by 5 mg/day each week to maintenance dose of 10 mg/day

  • CPA: 2 mg/kg/day oral from day 1; dose reduced for side effects. Continued for 6 months after remission


Subsequent maintenance therapy is not mentioned
Outcomes
  • Death

  • ESKD

  • SCr

  • Adverse events

Notes
  • No results were extractable from the published paper

  • Funding source: not reported

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 Low risk Open‐label study, unable to blind interventions; 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 Low risk All patients accounted for
Selective reporting (reporting bias) High risk Data could not be extracted for analysis
Other bias Unclear risk Funding source not reported