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

SMART TX Study 2010.

Methods

  • Study design: parallel RCT, randomised 10 to 24 days post‐transplant

  • Study duration: recruitment February 2005 to April 2007

  • Duration of follow‐up: 12 months
Participants

  • Setting: multicentre (6 centres)

  • Country: Germany

  • Patients aged 8 and 65 years, scheduled to receive a single organ kidney transplant from a living or a deceased donor

  • Number: treatment group (69); control group (71)

  • Mean age ± SD (years): treatment group (47.0 ± 10.8); control group (47.1 ± 11.1)

  • Sex (males): treatment group (65.2%); control group (70.4%)

  • Exclusion criteria: current or historic PRA > 30%; positive cross‐match; gastrointestinal disorder that might interfere with the ability to absorb oral medication; history of cancer, except successfully treated; receipt of a new investigational drug within the previous 3 months and a BMI > 32 kg/m2; WCC ≥ 4000 mm3; platelet count ≥100,000 mm3; fasting triglycerides ≤ 4.6 mmol/L; fasting cholesterol ≤ 7.8 mmol/L
Interventions Treatment group

  • SRL: 01 mg/kg (loading dose) then 2 to 4 mg/d; target trough level 8 to 12 ng/mL

  • CsA: reduced to 50% then eliminated by day 3

  • MMF: initially decreased to 1.5 g/d


Control group

  • CsA trough levels: 150 to 200 ng/mL, then 100 to 150 ng/mL (month 4)

  • MMF: 2 g/d


Both groups

  • ATG induction (modified after 1st 25 patients)

  • PRED: according to local protocol

  • CsA tough levels: 200 to 250 ng/mL (for 1st 2 to 3 weeks)
Outcomes

  • BPAR

  • Graft survival

  • Patient survival

  • Treatment failure

  • Change in graft function

  • Infections
Notes

  • Funding source: "This study was supported by Wyeth Pharma (Munster, Germany) and Fresenius Biotech (Munich, Germany"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A permuted block randomisation scheme was used to assign trial participants to one of the treatment groups
Allocation concealment (selection bias) Low risk Allocation concealment was secured by a centralized distribution of sequentially numbered, opaque, sealed envelopes, and a confirmatory randomisation fax to the clinical research organization
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 All possible outcomes reported as ITT
Selective reporting (reporting bias) Low risk Pre specified outcomes reported
Other bias High risk Funded by Wyeth and Fresenius