drugset / Trial / NCT00861536

Comparison of ATG to Thymoglobuline in Renal Transplantation

NCT00861536

Phase 4 Completed 40 enrolled University Hospital, Basel, Switzerland
RandomizedParallel-groupOpen-labelTreatment

Summary

An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.

Timeline

Start
2009-01
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Thymoglobulin Protein / enzyme biologic 3 mg/kg
Comparator Thymoglobuline Genzyme Unknown 1.5 mg/kg

Indications

No indication recorded.