Skip to main content
. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

Harmankaya 2002.

Methods

  • Study design: parallel, 2‐arm RCT

  • Time frame: not reported

  • Duration of follow‐up: median 60 months (range 12 to 120 months)
Participants

  • Setting: single centre

  • Country: Turkey

  • Inclusion criteria: biopsy‐proven IgAN and isolated haematuria and well‐reserved kidney function (mean CrCl 89.2 ± 10.2 mL/min)

  • Number (analysed/randomised): treatment group (21/21); control group (22/22)

  • Mean age, range (years): treatment group (25, 13 to 42); control group (27, 17 to 63)

  • Sex (M/F): treatment group (15/6); control group (14/8)

  • Exclusion criteria: secondary causes of IgAN (SLE, HSP); hepatic disease
Interventions Treatment group

  • Prednisolone: 40 mg/d for 2 months, reduced to 20 mg/d and then slowly tapered over 2 months

  • AZA: 100 mg/d for 4 months


Control group

  • No treatment


Co‐interventions

  • Not reported
Outcomes

  • ESKD

  • Renal histology

  • Adverse events
Notes

  • Funding: not reported

  • Trials registration identification number: not applicable
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 High risk Blinding of outcome assessment not specifically reported. Key outcomes were objective laboratory measures and were unlikely to be affected by any knowledge of treatment allocation. Reporting of adverse events may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes High risk Not all participant data were reported
Selective reporting (reporting bias) High risk There was no pre‐specified protocol identified for this study. The study did not report extractable data for the key outcomes that would be expected for a study of this type (e.g., death (any cause), GFR loss, infection, malignancy)
Other bias Low risk The study appears to be free of other sources of bias