Kidney Transplant Clinical Trials

Clinical trials related to Kidney Transplant Procedure

Induction in Sensitized Kidney Transplant Recipients Without Preexisting Donor-specific antiboDies: a Randomized Multicentre Trial Between a Lymphocyte Depleting and Basiliximab.

Status: Not_yet_recruiting
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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 actual immunological risk of the sensitized KTRs without donor specific antibodies (DSAs) is still debated. The benefit-risk equation of lymphocyte depleting antibodies (versus IL2R antagonists) is not known in sensitized KTRs without DSAs. This clinical trial will compare the efficacy and safety of basiliximab and rATG in sensitized KTR without pre-existing DSAs detected by Luminex.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• 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%

• Ability for participant to comply with the requirements of the study

• Written informed consent obtained from the participant

• Participants covered by or entitled to social security.

Time Frame
Start Date: 2023-09-12
Completion Date: 2030-03-01
Participants
Target number of participants: 244
Treatments
Experimental: rabbit antithymocyte globulin (rATG)
The infusion of rATG (Thymoglobulin® (1.5mg/kg/day, maximum daily dose: 100 mg)) starts just after the randomization pre-operatively on a functional arteriovenous fistula or a high-flow venous catheter during 3 to 7 days until efficient tacrolimus level is obtained. The recommended initial tacrolimus dose is Prograf® 0.1mg/kg/day twice day.
Active_comparator: Basiliximab
The infusion of Basiliximab (Simulect® (20mg)) starts before the surgery on peripheral vein for 15 minutes and the second infusion at day 4.
Sponsors
Leads: University Hospital, Tours

This content was sourced from clinicaltrials.gov