Prospective Multicentric, Randomized, Open-labeled, in Parallel Groups, Study to Assess the Benefit/Risk of an Induction Treatment With Anti-Thymocyte Globulins (ATG) Versus Basiliximab in Kidney Transplant Patients Displaying Low Immunological Risk But High Susceptibility to Delayed Graft Function.
Overview
- Phase
- Phase 4
- Intervention
- Anti-Thymocyte Globulins treatment
- Conditions
- Kidney Transplantation
- Sponsor
- Nantes University Hospital
- Enrollment
- 19
- Locations
- 4
- Primary Endpoint
- Occurrence of a delayed graft function
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
ATG
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).
Intervention: Anti-Thymocyte Globulins treatment
Basiliximab
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).
Intervention: Basiliximab treatment
Outcomes
Primary Outcomes
Occurrence of a delayed graft function
Time Frame: 7 days
Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation.
Secondary Outcomes
- Evolution of estimated glomerular filtration rate (eGFR)(15 days)
- Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).(3 months)
- Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation(3 months)
- Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.(3 months)
- Duration of the delayed graft function(7 days)
- Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR(3 months)
- Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation(3 months)
- Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.(15 days)