Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies

Recruiting Phase 3 Interventional Study
Renal Transplant Rejection Induction Therapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 79
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
244 (estimated)
Sponsor
University Hospital, Tours · Other
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About This Trial
Induction therapy decreases the rate of acute allograft rejection in kidney transplant recipients (KTRs) and is strongly recommended. Polyclonal lymphocyte-depleting antibodies and interleukin-2 receptor (IL2R) antagonists are therefore widely used around the world, with a leading position for rabbit anti-thymocyte globulin (rATG, Thymoglobulin®) and basiliximab (Simulect®), respectively. The actu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients aged between 18-79 * Registered on the transplant waiting list * At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000 (MFI threshold in agreement with French kidney allocation system.) * Graft incompatibility rate (TGI) \< 85% *…
Contacts

Annabelle GOUMARD

0247477263

a.goumard@arauco.fr

CONTACT

Philippe GATAULT

philippe.gatault@univ-tours.fr

CONTACT