Minimizing Tacrolimus in Low Immunological Risk Kidney Transplant Patients
Official title: Prospective, Multicenter, Randomized, Open-label, Parallel-group Controlled Phase 3 Study of Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
Run by Nantes University Hospital · NCT06235892 · Data updated 2026-11-12
This study is testing if reducing the use of Tacrolimus, a medication for kidney transplant patients at low risk of rejection, is safe and helps keep their kidney function stable compared to the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 3 sites (Nantes and 2 other locations) |
| Status | Recruiting |
| Started | December 10, 2024 |
| Main results expected | June 10, 2028 |
| Study ends | December 10, 2028 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT06235892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients who have undergone their first kidney transplantation and meet specific immunological criteria indicating low risk of graft failure.
✕Probably not a fit
Patients who have had multiple kidney transplants or those with high immunological risk factors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to validate the AGORA algorithm, which uses non-invasive biomarkers to identify kidney transplant recipients at low immunological risk for graft failure. By selecting these patients, the study will assess the safety and efficacy of minimizing Tacrolimus, an immunosuppressive medication, compared to standard care. The primary outcome will be kidney function measured 18 months after the minimization period, focusing on patients one year post-transplantation. The trial involves multiple locations, including Nantes, Oslo, and Barcelona.
Why it matters
Potential benefit: If successful, this approach could lead to safer immunosuppression strategies for kidney transplant recipients, reducing the risk of side effects associated with long-term Tacrolimus use.
How similar studies have gone: Other studies have shown promise in minimizing immunosuppression in low-risk transplant patients, suggesting that this approach may be viable.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHU de NANTES
Nantes, France Recruiting -
Oslo University Hospital
Oslo, Norway Not yet recruiting -
Hospital Universitari Vall d'Hebron
Barcelona, Spain Not yet recruiting
Study contacts
- Study coordinator: Magali GIRAL
- Email: magali.giral@chu-nantes.fr
- Phone: +33240087443
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.