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New treatment option for Renal Transplant Rejection
Official title Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
ClinicalTrials.gov ID: NCT05385432
What this study is testing
What is Rabbit Anti thymocyte globulin (rATG)?
Rabbit Anti thymocyte globulin (rATG) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for renal transplant rejection.
Also referred to as Maintenance immunosuppressive regimen is the same in experimental and control groups combining tacrolimus, mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS) and steroids.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- 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...
- Graft incompatibility rate (TGI) \< 85%
- Ability for participant to comply with the requirements of the study
You likely can't join if
- DSA (negative virtual crossmatch 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...
- Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)
- Incompatible ABO transplantation
- Leukopenia lower than 3000/mm3
See the full eligibility 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 participant to comply with the requirements of the study
- Written informed consent obtained from the participant
- Participants covered by or entitled to social security.
- DSA (negative virtual crossmatch 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 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 (\< 5 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma).History of some solid cancer (prostate, breast) can be reduced (\<2 years), depending on the prognosis for cancer...
- 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 rabbit proteins, basiliximab including the product excipients
- Contra-indication to tacrolimus,mycophenolic acid ans steroids
- Pregnant or breastfeeding woman, or woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed...
- Patient under judicial protection, deprivation of liberty
- Participation in other treatment research with an investigational drug or medical device.
The study team makes the final eligibility decision.
Where it's taking place
- Tours, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tours, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.