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

Study acronym: INSTEAD
StatusRecruiting
PhasePhase 3
Started2023-11-07
View on ClinicalTrials.gov ↗

Amendment history

2026-06-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-03-01→2030-12-30
Completion date2030-03-01→2030-12-30
Start dateestimated 2023-09-12→confirmed 2023-11-07
2023-09-01
Study Status, Study Design, Outcome Measures, Eligibility v2
PhasePhase 4→Phase 3
Primary completion date2026-07-15→2027-03-01
Completion date2028-07-15→2030-03-01
Start date2023-01-15→2023-09-12
Eligibility criteria+521 characters
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% Ability for particip [...] smatch with MFI threshold at 1000) Combined transplantation Usual contraindications to a kidney transplantation such as morbid obesity (BMI > 40 kg/m2), active drug abuse, uncontrolled psychiatric disease, or decompensated heart failure Beneficiaries of kidney transplants from donations aft [...] [...]
Secondary endpoints9 to 10 entries
Assessment of the safety
2022-09-22
Study Status, Eligibility v1
Primary completion date2024-12-15→2026-07-15
Completion date2027-12-15→2028-07-15
Start date2022-09-15→2023-01-15
Eligibility criteria+85 characters
[...] ipant Participants covered by or entitled to social security. Exclusion Criteria: DSA (positivenegative virtual crossmatch with MFI threshold at 5001000) Patient under legal protection, under guardianship or curatorship Combined transplantation Beneficiaries of kidney transplants [...] mpatible ABO transplantation Leukopenia lower than 3000/mm3 Thrombocytopenia (platelets < 50G/L) Donor EBV positivePositive / recipientRecipient EBV Negative Active HIV infection (positive viral charge) History of solid cancer (< 2 years), except to skin carcinom [...] ception, or having a desire to conceive within 12 months [...]
2022-05-17
Original filing
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.
Trial Details
NCT Number NCT05385432
Lead Sponsor University Hospital, Tours
Conditions Renal Transplant Rejection, Induction Therapy
Enrollment 244 participants
Start Date 2023-11-07
Primary Completion 2030-12-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18