ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF

NCT02056938 ↗

Phase 4 Terminated 19 enrolled Nantes University Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the following randomized open label trial is to demonstrate how low immunological risk patients (no anti HLA immunization and first kidney transplantation) but diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from induction with ATG for preventing delayed graft function compared to Basiliximab.

Timeline

Start: 2014-06
Primary completion: 2017-02
Completion: 2017-02

Publications

Chapal M, Foucher Y, Marguerite M, Neau K, Papuchon E, Daguin P, Morelon E, Mourad G, Cassuto E, Ladriere M, Legendre C, Giral M. PREventing Delayed Graft Function by Driving Immunosuppressive InduCtion Treatment (PREDICT-DGF): study protocol for a randomized controlled trial. Trials. 2015 Jun 23;16:282. doi: 10.1186/s13063-015-0807-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Basiliximab	Monoclonal antibody	20 mg	Intravenous
Subject	antithymocyte globulins	Unknown	1.5 mg/kg	Intravenous

Indications

No indication recorded.