drugset / Trial / NCT02102854

Single Dose rATG for Renal Allograft Rejection

NCT02102854 ↗

Phase 4 Unknown 30 enrolled The Methodist Hospital Research Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter.Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration including correlation to length of hospital stay and hospital costs.

Timeline

Start
2014-03
Primary completion
2021-03
Completion
2021-10

Drugs

EvaluationDrugModalityDoseRoute
Subject rATG Protein / enzyme biologic 1.5 mg/kg Intravenous
Subject rATG Protein / enzyme biologic 3 mg/kg Intravenous