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. 2017 Jul 21;2017(7):CD006750. doi: 10.1002/14651858.CD006750.pub2

Suwelack 2002.

Methods

  • Study design: parallel RCT

  • Study duration: recruitment not reported

  • Duration of follow‐up: 35 weeks
Participants

  • Setting: single centre

  • Country: Germany

  • Patient at least 1 year post‐transplant, with SCr < 4 mg/dL and a biopsy‐confirmed diagnosis of CAN

  • Number: treatment group (18); control group (20)

  • Mean age ± SD (years): treatment group (47.9 ± 13.1); control group (22.90 ± 0.95)

  • Sex (M/F): treatment group (12/6); control group (16/4)

  • Exclusion criteria: received MMF or experienced an AR episode in the previous 6 months; diabetes; severe infections; malignancies; WCC < 3000/µL; Hb < 9 g/dL; gastrointestinal ulcers or other gastrointestinal conditions that could impair absorption of medication
Interventions Treatment group

  • CNI withdrawal from week 4: dose reduced by 33% every 2 weeks until complete withdrawal

  • MMF

  • PRED


Control group

  • CNI

  • MMF

  • PRED


Both groups

  • CNI (weeks 1 to 3)

    • CsA trough levels: 80 to 120 ng/mL

    • TAC trough levels: 4 to 7 ng/mL

  • MMF
Outcomes

  • Kidney function: slope of reciprocal SCr (dL/mg/month) at 8 months

  • Proteinuria

  • AR: BPAR and clinical rejection

  • Infection

  • Malignancy

  • Gastrointestinal disorders

  • BP

  • Number of antihypertensive medications required

  • Graft loss
Notes

  • Funding source: "Funding for this study was provided by F. Hoffman‐La Roche AG, Grenzach‐Wyhlen, Germany"
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 No missing outcome data noted
Selective reporting (reporting bias) Low risk Pre specified outcomes reported
Other bias High risk Funded by Hoffman‐La Roche