Kidney transplant trial tests which drug better prevents rejection
NCT ID NCT05385432
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial compares two induction therapies—rabbit anti-thymocyte globulin (rATG) and basiliximab—in 244 sensitized kidney transplant recipients who do not have pre-existing donor-specific antibodies. The goal is to see which drug better prevents biopsy-proven acute rejection within the first year after transplant. Participants will receive standard maintenance immunosuppression alongside the assigned induction therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rabbit anti-thymocyte globulin (rATG) and basiliximab
- What this could lead to
- If successful, this trial could show which induction therapy is safer and more effective for preventing kidney transplant rejection in sensitized patients without donor-specific antibodies.
- What could go wrong
- This is a phase 3 trial, but results may not apply to all patients. Both drugs have known risks like infection and side effects, and the benefit of one over the other may be small or absent.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 244 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2023
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 79 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 participant 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 (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 recurrence as assessed by the oncologist. * 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 for inclusion. * Patient under judicial protection, deprivation of liberty * Participation in other interventional research with an investigational drug or medical device.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for End-stage renal disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
01-TOURS
RECRUITINGTours, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a deep breath and a hint of lemongrass take the sting out of dialysis needles?
- Can better training get doctors to talk about what matters most to dying veterans?
- Can pedaling during dialysis make red blood cells more flexible?
- 30,000 dialysis patients tracked to map what works
- Donated artery grafts tested as lifeline for dialysis patients
- Does better dialysis keep parathyroid hormone in check?