ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF (PREDICT-DGF)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|