NCT06235892 Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
| NCT ID | NCT06235892 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nantes University Hospital |
| Condition | Organ Grafts |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2028-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2024-12-10 with a primary completion date of 2028-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is that validation of the non-invasive biomarkers of the AGORA algorithm should make it possible to select patients with a very low immunological risk of graft failure to authorize safe minimization of their immunosuppression for adult patients at one-year post kidney transplantation. The main question of the AGORAC trial is to demonstrate the impact of TACROLIMUS minimization using AGORA algorithm compared to standard of care on the kidney function 18 months after the minimization period.
Eligibility Criteria
Inclusion Criteria: * First kidney transplantation * Living or brain death or * Donation after circulatory death (Maastricht 3) donor,Compatible for ABO group with the donor, * cPRA (Panel Reactive Antibody Calculated ) (or TGI: Incompatible Graft Rate )\<20% on the day of the transplantation and no DSA (MFI \<500) at pre transplant and at the time of the inclusion at one-year post transplantation (between 350 and 515 days after the transplantation. * Eplet Mismatchs \<= 14 * Normal or IFTA 1-2 histology on one-year surveillance biopsy. * Patient insured under a health insurance scheme, according to national regulation. * Patient (of childbearing age) with effective contraception. * Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS (Mycophenolate Sodium) +/- Corticosteroid (CS) Exclusion Criteria: * Donation after circulatory death maastricht 2 (uncontrolled) and maastricht 1 * Pregnant women (serum or urine test), breastfeeding women * Patient under legal protection (incl. under guardianship or trusteeship) * Participation to a drug interventional study within 1 month prior to the inclusion * Any retransplantation and combined transplantations and also other organ previous transplantations * History of lymphoproliferative disorders * Diagnosis of a malignant disease (according to the type of malignancy) * Hepatitis C antibody or hepatitis B surface antigen (HbsAg) positive patient or HIV infection
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06235892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Organ Grafts. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06235892 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06235892 currently recruiting?
Yes, NCT06235892 is actively recruiting participants. Contact the research team at magali.giral@chu-nantes.fr for enrollment information.
Where is the NCT06235892 trial being conducted?
This trial is being conducted at Nantes, France, Oslo, Norway, Barcelona, Spain.
Who is sponsoring the NCT06235892 clinical trial?
NCT06235892 is sponsored by Nantes University Hospital. The trial plans to enroll 300 participants.