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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Anti-Thymocyte Globulins treatment
* Drug: Basiliximab treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATG<br>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). | Drug: Anti-Thymocyte Globulins treatment<br> <br> |
| Active Comparator: Basiliximab<br>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). | Drug: Basiliximab treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a delayed graft function | Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the delayed graft function | 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. | 7 days | 
| Evolution of estimated glomerular filtration rate (eGFR) | 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. | 15 days | 
| 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 | 
| Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis). |  | 3 months | 
| Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR |  | 3 months | 
| Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation. |  | 3 months | 
| Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation | Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation will be evaluated by computerized quantification. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation, kidney, delayed graft function, induction therapy, personalized medicine, First kidney transplantation, No anti HLA immunization prior transplantation, Risk of DGF higher than 40% calculated byt he score DGFS