INduction in Sensitized kidney Transplant recipients without pre-Existing donor-specific AntiboDies: a randomized multicentre trial between a lymphocyte depleting and basiliximab (INSTEAD)

Phase 1

Recruiting

• Conditions: Kidney transplant; MedDRA version: 20.0Level: LLTClassification code: 10023438Term: Kidney transplant Class: 10042613; Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

• Registration Number: CTIS2022-502007-30-00
• Lead Sponsor: Centre Hospitalier Regional Universitaire De Tours

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

Patients aged between 18-79, At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI = 2000, Graft incompatibility rate (TGI) < 85%, Ability for participant to understand the nature and objectives of the study; to comply with the requirements of the study, Written informed consent obtained from the participant, Participants covered by or entitled to social security

Exclusion Criteria

DSA (positive virtual crossmatch with MFI threshold at 1000), History of lymphoma, Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin greater than 3 times normal, Known hypersensitivity or contra-indication to Thymoglobulin® (rATG) or Simulect® (basiliximab) including the product excipients, Contra-indication to tacrolimus, mycophenolic acid and steroids, Pregnant or breastfeeding woman, or woman of childbearing potential not using an effective method of contraception, or having a desire to conceive, within 12 months of transplantation, Patient under judicial protection, deprivation of liberty, Participation in another interventional research with an investigational drug or medical device, Combined transplantation, Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II), Incompatible ABO transplantation, Leukopenia lower than 3000/mm3, Thrombocytopenia (platelets < 50G/L), Donor EBV Positive / Recipient EBV Negative, Active HIV infection (positive viral charge), History of solid cancer (< 2 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified