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

• Status: Terminated
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Antibodies, Monoclonal; Antilymphocyte Serum; Basiliximab

Criteria

Inclusion Criteria:

• Adults

• First kidney transplantation

• No anti HLA immunization prior transplantation

• A risk of DGF higher than 40% calculated by the score DGFS (DGFS >= 0.4)

• Written informed consent

Exclusion Criteria:

• Previous or combined other transplantations

• Non heart beating donors

• Living donors

• Pre-emptive transplantation

• Patients on peritoneal dialysis

• Leucopenia lower than 3000/mm3

• Thrombopenia lower than 100 000/mm3

• Donor EBV positive / recipient EBV Negative

• Pregnant or lactating women

• Patients under guardianship

• Previous and current history of cancer and/or lymphoma

• Current history of HCV or HBV or HIV infection