RMR Study 2001.

Methods	Study design: parallel RCT Study duration: recruitment May 1998 to June 1999 Duration of follow‐up: 60 months
Participants	Setting: multicentre (57 centres) Country: Europe, Australia, Canada 1st or 2nd kidney transplant recipients aged > 13 years; cadaveric or living donors; WCC ≥ 4000/mm3, platelet count ≥ 100,000/mm3, fasting triglycerides ≤ 4.6 mmol/L, fasting cholesterol ≤ 7.8 mmol/L, randomised 3 months post‐transplant Number: treatment group (215); control group (215) Mean age (years): treatment group (44.6); control group (45.8) Sex (males): treatment group (61.9%); control group (66.5%) Exclusion criteria: active systemic or localized major infection; chronic antiarrhythmic therapy for ventricular arrhythmia; other cardiac abnormality contraindicating general anaesthesia or surgery; history of malignant disease; investigational drug use in the previous 4 weeks; active gastrointestinal disorders interfering with drug absorption; planned use of antibody induction therapy at the time of transplantation; known hypersensitivity to any study drugs
Interventions	Treatment group CsA: gradually decreased and eliminated over 4 to 6 weeks High dose SRL trough levels: 20 to 30 ng/mL Steroids Control group CsA trough levels: 75 to 200 ng/mL Standard dose SRL: 2 mg/d adjusted to maintain trough levels > 5 ng/mL Steroids Both groups SRL: 6 mg loading dose then 2 mg/d adjusted to maintain trough levels > 5 ng/mL CsA trough levels: 200 to 400 ng/mL (month 1), 150 to 300 ng/mL (until randomisation) Steroids: as per local protocol tapered to 5 to 10 mg/d by month 6
Outcomes	Graft survival at 12, 24 and 36 months SCr BPAR Patient survival PTLD Infection
Notes	Funding source: "This work was supported by a grant from Wyeth‐Ayerst Research, Philadelphia, Pennsylvania"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study was described as randomised, method of randomisation was not reported
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	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing data accounted for outcome reporting
Selective reporting (reporting bias)	Low risk	Prespecified outcomes reported
Other bias	High risk	Funded by Wyeth‐Ayerst Research