ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF (PREDICT-DGF)
|ClinicalTrials.gov Identifier: NCT02056938|
Recruitment Status : Terminated (recruitment issues)
First Posted : February 6, 2014
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: Anti-Thymocyte Globulins treatment Drug: Basiliximab treatment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
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
Active Comparator: 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).
Drug: Basiliximab treatment
- 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.
- Duration of the delayed graft function [ Time Frame: 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.
- Evolution of estimated glomerular filtration rate (eGFR) [ Time Frame: 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.
- Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation [ Time Frame: 3 months ]
- Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge. [ Time Frame: 15 days ]
- Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis). [ Time Frame: 3 months ]
- Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR [ Time Frame: 3 months ]
- Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation. [ Time Frame: 3 months ]
- Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation [ Time Frame: 3 months ]Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation will be evaluated by computerized quantification.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056938
|Universitary hospital of Lyon|
|Lyon, France, 69437|
|Nantes Universitary hospital|
|Nantes, France, 44093|
|Universitary hospital of Nice|
|Nice, France, 06002|
|Paris, France, 75045|
|Principal Investigator:||Magali GIRAL, Professor||Nantes universitary hospital|