TerminatedPhase 4

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

Stopped: recruitment issues

France19 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Occurrence of a delayed graft function

Timeframe: 7 days

Trial details

NCT IDNCT02056938

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02

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