ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF
- Conditions
- Kidney Transplantation
- Interventions
- Drug: Anti-Thymocyte Globulins treatment
- Registration Number
- NCT02056938
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Basiliximab Basiliximab treatment 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). ATG Anti-Thymocyte Globulins treatment 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).
- Primary Outcome Measures
Name Time Method Occurrence of a delayed graft function 7 days Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation.
- Secondary Outcome Measures
Name Time Method Evolution of estimated glomerular filtration rate (eGFR) 15 days Evolution of eGFR from day 1 to day 7 post transplantation then every two days until hospital discharge. Only eGFR assessments at least 48 hours after the last day of dialysis will be considered.
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 Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation will be evaluated by computerized quantification.
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 Duration of the DGF defined by the number of days after the transplantation to reach an estimated glomerular filtration rate (eGFR) above 10 mL/min. Only eGFR assessments at least 48 hours after the last day of dialysis will be considered.
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
Trial Locations
- Locations (4)
Nantes Universitary hospital
🇫🇷Nantes, France
Universitary hospital of Lyon
🇫🇷Lyon, France
Necker Hospital
🇫🇷Paris, France
Universitary hospital of Nice
🇫🇷Nice, France