ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF (PREDICT-DGF)

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Anti-Thymocyte Globulins treatment; Drug: Basiliximab treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02056938

RC14_0051

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

ATG

Experimental group

Description:

The first infusion of Thymoglobuline® begins before the kidney reperfusion. In case of a patient with a functional arteriovenous fistula or a high-flow venous catheter, the infusion of Thymoglobuline® can begin just after the randomization pre operatively. When the patient has no available arteriovenous fistula for the Thymoglobuline® infusion, it is necessary to install a high-flow vein (central vein) by the anesthesiologist, and to begin the perfusion as soon as possible intra-operatively before the reperfusion of the kidney. The dose of Thymoglobuline® per infusion is 1.5mg/kg. The duration of each infusion is between 6 to 24 hours. The total duration of the Thymoglobuline® administration is 4 days (starting at and including the first day of the surgery).

Treatment:

Drug: Anti-Thymocyte Globulins treatment

Basiliximab

Active Comparator group

Description:

The first infusion of Simulect® begins within the two hours before the surgery. There is no need of central venous catheter or arteriovenous fistula to infuse the Simulect®. The duration of the infusion is 30 minutes. Each dose of Simulect® is 20 mg. The first infusion of Simulect® is displayed on Day 0 (within the two hours before the surgery) and the second infusion 3 days afterward (Day 4).

Treatment:

Drug: Basiliximab treatment