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. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

Kobayashi 1996.

Methods
  • Study design: parallel, 2‐arm quasi‐RCT

  • Time frame: April 1972 to December 1983 (patient diagnosis)

  • Duration of follow‐up: 10 years

Participants
  • Setting: single renal unit

  • Country: Japan

  • Inclusion criteria: primary diagnosis of IgAN, proteinuria between 1 to 2 g/d; CrCl ≥ 70 mL/min; histological severity score ≥ 7

  • Number (analysed/randomised): treatment group (20/31); control group (26/59)

  • Mean age ± SD (years): treatment group (30 ± 7); control group (33 ± 10)

  • Sex (M/F): treatment group (12/8); control group (12/14)

  • Exclusion criteria: not reported

Interventions Treatment group
  • Prednisolone: 40 mg/d for 3 weeks, 30, 25 and then 20 mg/d for 8 weeks; maintained at 15 mg/d for 6 months and then further tapered (most of the patients received steroid therapy for 18 months)

  • Antithrombocyte drugs were prescribed after discontinuation of steroid therapy until final observation


Control group
  • Antithrombocyte drugs until final observation


Co‐interventions
  • Not reported

Outcomes
  • ESKD

  • CrCl

  • Urinary protein excretion

Notes
  • Funding: supported by grants from the Ministry of Health and Welfare, Japan

  • Trials registration identification number: not applicable

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Prospectively divided into two groups according to the order of renal biopsy
Allocation concealment (selection bias) High risk Prospectively divided into two groups according to the order of renal biopsy. This is a quasi‐randomised study design
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Low 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
Incomplete outcome data (attrition bias) 
 All outcomes High risk 11/31 patients in the treatment group and 33/59 patients from the control group were excluded from the analyses
Selective reporting (reporting bias) High risk Key outcomes expected for this type of study (death (any cause), malignancy, infection) were not reported
Other bias High risk The participants received differential prescribing of anti‐thrombotic drugs during follow‐up. There was imbalance in sex and history of hypertension at baseline