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

Lai 1987.

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

  • Time frame: not reported

  • Duration of follow‐up: 6 months

Participants
  • Setting: single centre

  • Country: Hong Kong

  • Inclusion criteria: 16 to 60 years, IgAN for 12 months or more diagnosed on renal biopsy; proteinuria ≥ 1.5 g/day

  • Number analysed/randomised: treatment group (9/11); placebo group (10/11)

  • Mean age ± SEM (years): treatment group (33.1 ± 1.4); placebo group (38.7 ± 4.1)

  • Sex (M/F): treatment group (4/5); placebo group (6/4)

  • Exclusion criteria: CrCl < 50 mL/min/1.73 m2; previous therapy with cytostatic agents such as antilymphocyte globulin; corticosteroid therapy within four weeks prior to the study; thrombo‐embolic diseases; active infection; malignancy; uncontrolled hypertension; impaired liver function; history of epilepsy; concomitant treatment with nephrotoxic drugs

Interventions Treatment group
  • Cyclosporin: 5 mg/kg/day in 2 equal doses for 12 weeks. Titrated to whole blood concentrations and dose adjusted if changes in SCr


Control group
  • Placebo: matched; 0.05 mL/kg/d


Co‐interventions
  • Nadolol to maintain BP < 150/90 mmHg

Outcomes
  • Urinary protein excretion

  • CrCl

  • SCr

Notes
  • Funding: "...supported by a grant from the Croucher Foundation. We thank Dr B von Graffenreid, immunology department, Sandoz Pharmaceuticals, Basle, Switzerland, for giving us the placebo."

  • Trials registration identification number: not applicable

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Computer generated. However, "All patients were given a number in the trial based on their order of entry"
Allocation concealment (selection bias) High risk All patients were given a number in the trial based on their order of entry, which determined their allocation to the treatment or placebo group
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Initially blinded however "We decided to reduce the dose of cyclosporin by 20% if plasma creatinine concentration exceeded 25% of the baseline value or the plasma cyclosporin trough concentration (concentration measured 12 hours after administration) reached 150 µg/l (evaluated by radioimmunoassay with a Sandoz kit). Similarly we decided to increase the dose of cyclosporin by 20% if the plasma cyclosporin trough concentration fell below 45 µg/l."
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not reported. The patients were interviewed by telephone weekly about any side effects. Interpretation of subjective outcomes may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes High risk Outcomes were reported for 9 participants in cyclosporin group and 10 participants in placebo group. However, in a secondary publication, there were 11 participants allocated to each treatment group
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 High risk Imbalance in baseline characteristics (age, plasma creatinine, urinary protein)