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. 2017 Jan 11;2017(1):CD004759. doi: 10.1002/14651858.CD004759.pub2

Stevens 2008.

Methods
  • Study design: parallel RCT; stratified into 6 groups: white versus non‐white, DD versus LD; listed for pancreas after kidney versus not listed

  • Study duration: April 2004 to December 2007

  • Study follow‐up: 6 months

Participants
  • Country: USA

  • Setting: single centre

  • Inclusion criteria: 18 to 64 years; LD or DD kidney transplant recipients; 1st or repeat transplant

  • Number (analysed/randomised): treatment group 1 (70/79); treatment group 2 (72/81)

  • Mean age ± SD (years): treatment group 1 (45.5 ± 12.4); treatment group 2 (49.3 ± 10.5)

  • Sex (M/F): treatment group 1 (46/24); treatment group 2 (45/27)

  • White‐Asian/other: treatment group 1 (62/8); treatment group 2 (61/11)

  • LD/DD: treatment group 1 (30/40); treatment group 2 (31/41)

  • Exclusion criteria: > 65 years; PRA > 75%; HLA‐identical recipients; required chronic steroids

Interventions Treatment group 1
  • Single high dose rATG: 6 mg Infused over 24 h in 1 L of normal saline, started in operating theatre, prior to re‐perfusion


Treatment group 2 
  • Split dose rATG: 4 x 1.5 mg doses over 7 days (day 0, 2, 4, 6)

    • 1st dose 1.5 mg/kg over 24 h, started before reperfusion

    • Subsequent doses in 250 mL over 6 to 12 h every 2nd day


Pre‐meds, immunosuppression, prophylaxis (both groups)
  • Pre‐med: MP, paracetamol, antihistamine

    • MP: 3 mg/kg every 6 h for 24 h

  • Immunosuppression

    • TAC: 1 to 3 mg twice daily when Cr < 3g/dL (trough target 4 to 6 ng/mL, 2 to 4 ng/mL after 3/12)

    • Sirolimus: 5 mg 4 times/d when SCr < 3 mg/dL, (trough 8 to 10 ng/mL to 3 months, 4 to 8 ng/mL after 3 months)

      • MMF: used if BMI > 32, 500 to 1000 mg twice/d

  • Prophylaxis

    • Valaciclovir for 3 months

    • Clotrimazole for 3 months

    • Co‐trimoxazole (or dapsone or aerosolized pentamidine if allergy) for PCP for 3 months

Outcomes
  • Kidney function (eGFR)

  • CAN by protocol biopsy at 6 months

  • Biopsy‐proven acute rejection

  • Patient survival

  • Graft survival

  • Safety profile

  • NODAT

Notes
  • Switch in maintenance immunosuppression at 6 months. Either CNI withdrawal and switch to MMF or continued on TAC. 50% of each group. These results not reported, therefore outcomes only to 6/12

  • Funding source: "supported by the Ann Goldstein‐Cheryl Cooper New Frontiers in Transplant Medicine Fund, a Research Support Fund grant from the Nebraska Medical Center and the University of Nebraska Medical Center and an unrestricted research grant from Genzyme, Inc"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk ‘Randomly generated treatment group assignments’ after stratification into 6 different groups
Allocation concealment (selection bias) Low risk ‘Sequentially numbered sealed envelopes’. 
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unlikely to influence outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All patient outcome data reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups
Selective reporting (reporting bias) High risk Primary outcomes not well reported (graphs only, no figures reported for kidney function)
Other bias Unclear risk Partly funded by Genzyme with unrestricted grant. (but ATG in both arms)