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.
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