ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF
NCT ID: NCT02056938
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
19 participants
INTERVENTIONAL
2014-06-30
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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).
Basiliximab treatment
Interventions
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Anti-Thymocyte Globulins treatment
Basiliximab treatment
Eligibility Criteria
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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
* 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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Magali GIRAL, Professor
Role: PRINCIPAL_INVESTIGATOR
Nantes universitary hospital
Locations
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Universitary hospital of Lyon
Lyon, , France
Nantes Universitary hospital
Nantes, , France
Universitary hospital of Nice
Nice, , France
Necker Hospital
Paris, , France
Countries
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References
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Chapal M, Foucher Y, Marguerite M, Neau K, Papuchon E, Daguin P, Morelon E, Mourad G, Cassuto E, Ladriere M, Legendre C, Giral M. PREventing Delayed Graft Function by Driving Immunosuppressive InduCtion Treatment (PREDICT-DGF): study protocol for a randomized controlled trial. Trials. 2015 Jun 23;16:282. doi: 10.1186/s13063-015-0807-x.
Other Identifiers
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RC14_0051
Identifier Type: -
Identifier Source: org_study_id