Induction in sensitized kidney transplant recipients without pre-existing donor-specific antibodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares two induction therapies, basiliximab and rATG, in sensitized adult kidney transplant candidates who do not have pre-existing donor-specific antibodies detected by Luminex. Eligible participants are on the transplant waiting list, have at least one anti-HLA antibody with MFI ≥ 2000, and meet standard transplant eligibility criteria. The study aims to determine differences in graft outcomes and safety between the two induction strategies in this specific immunological risk group. Biopsy-proven rejection, graft survival, and treatment-related adverse events will be monitored to inform optimal induction choices. The trial is conducted under the lead sponsorship of University Hospital, Tours, and involves multiple centers within Tours, France.

Why it matters

Who can join: the full rules

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.

Where it's running

• 01-Tours
  Tours, France Recruiting

Study contacts

• Study coordinator: Annabelle GOUMARD
• Email: a.goumard@arauco.fr
• Phone: 0247477263

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• QL1706 with chemotherapy induction followed by immunotherapy consolidation in limited-stage SCLC after chemoradiotherapy

  This study tests if QL1706 given with chemotherapy induction can improve outcomes for adults with limited-stage small cell lung cancer after chemoradiation, with follow-up immunotherapy consolidation and biomarker analysis.

  Recruiting Phase 2 Shanghai Chest Hospital · Shanghai · NCT07091305

• Iparomlimab/Tuvorlimab (QL1706) plus modified TPF induction for locally advanced nasopharyngeal carcinoma

  This trial will test whether adding the dual-antibody Iparomlimab/Tuvorlimab (QL‑1706) to a modified TPF chemotherapy regimen as induction therapy helps adults with newly diagnosed, locally advanced nasopharyngeal carcinoma.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07085234

• Comparing two and three cycles of chemotherapy with immunotherapy for advanced nasopharyngeal cancer

  This study is testing whether two cycles of chemotherapy combined with immunotherapy can help people with advanced nasopharyngeal cancer just as much as three cycles, but with fewer side effects.

  Recruiting at 3 sites Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 2 other locations · NCT06811844

• Combining immunotherapy and chemoradiotherapy for esophageal cancer treatment

  This study is testing if combining a new immunotherapy drug with traditional chemoradiotherapy can help people with advanced esophageal cancer have better treatment results.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Anyang, Henan and 2 other locations · NCT06421376

• Combined kidney and blood stem cell transplant from a sibling donor

  This study is testing a new treatment for kidney transplant recipients to see if using a sibling's blood stem cells can help them accept their new kidney without needing lifelong medications to prevent rejection.

  Recruiting Phase 1/2 University of California, Los Angeles · Los Angeles, California · NCT03707262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.