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INduction in Sensitized kidney Transplant recipients without pre-Existing donor-specific AntiboDies: a randomized multicentre trial between a lymphocyte depleting and basiliximab (INSTEAD)
EU CTIS ID: 2022-502007-30-00
What this study is testing
Demonstrate that rATG is more efficient than basiliximab to prevent biopsy-proven acute rejection (BPAR) during the first post-transplantation year in sensitized KTR without pre-existing DSAs
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.