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. 2012 Oct 17;2012(10):CD008176. doi: 10.1002/14651858.CD008176.pub2

Land 1994.

Methods
  • Study design: parallel RCT

  • Time frame: January 1987 to October 1988

Participants Inclusion criteria
  • Setting: single centre

  • Country: Germany

  • Patients who had received a cadaveric kidney transplant

  • Number: treatment group (81); control group (96)

  • Mean age ± SD: treatment group (45.5 ± 12.0); control group (45.6 ± 13.0)

  • Sex (M/F): treatment group (53/28); control group (77/19)


Exclusion criteria: NS
Interventions
  • Treatment group

    • Recombinant human superoxide dismutase (rh‐SOD) 200 mg in 50 mL saline

  • Control group

    • 200 mg sucrose in 50 mL saline as placebo

Outcomes
  • All‐cause mortality

    • Patient and graft survival rates within the first year and long term results included 4 year graft and patient survival rates

  • Chronic progressive transplant dysfunction requiring dialysis

Notes Retrospective analysis of data collected in prospective RCT (double‐blinded and placebo controlled)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study reports randomisation of patients, however, procedure was not described
Allocation concealment (selection bias) Unclear risk One of the authors (HS) of the study (although not involved in the patients' care) received the "randomisation code". This author was responsible for collecting all information about study. Study reports that the physicians in charge and the patients were not informed about the initial treatment. No information was provided regarding randomisation methodology
Blinding (performance bias and detection bias) 
 All outcomes Low risk Study reported the use of double blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Reported complete follow‐up, no information regarding the conduct of analyses based on the intention‐to‐treat principle
Selective reporting (reporting bias) Low risk The study protocol is not separately available but the published report includes all expected outcomes
Other bias High risk Funding: Two authors employees of 1) Shaman Pharmaceuticals (San Carlos, CA) and 2) The Lipsome Company Inc (Princeton, NJ)