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Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure

Study acronym: AGORAC
StatusRecruiting
PhasePhase 3
Started2024-12-10
View on ClinicalTrials.gov ↗

Amendment history

2026-06-02
Study Status, Study Design v4
Primary completion date2026-08-10→2028-06-10
Completion date2026-10-10→2028-12-10
Enrollment target332→300
2025-06-10
Study Status, Eligibility, Contacts/Locations v3
Eligibility criteria+22 characters
[...] tation (between 350 and 515 days after the transplantation. Eplet Mismatchs <= 14 Normal or IFTA 1-2 histology on one-year surveillance biopsy [...]
2024-12-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-10→confirmed 2024-12-10
Study sitesdetails revised at 3 of 3 sites
2024-02-15
Study Identification, Study Status, Outcome Measures, IPDSharing v1
Secondary endpoints8 entries, revised
Change in quality of life estimated using the EQ-5D ( EuroQol instrument - dimensions) questionnaire fulfilled by patients at baseline, Month 3, Month 6, Month 9, Month 12, Month15 and Month18
Study title-17 characters
Phase 3 Study of Tacrolimus Minimization in Kidney Transplant Recipients Sele [...]
2024-01-23
Original filing
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.
Trial Details
NCT Number NCT06235892
Lead Sponsor Nantes University Hospital
Conditions Organ Grafts
Enrollment 300 participants
Start Date 2024-12-10
Primary Completion 2028-06-10 (estimated)
Study Completion 2028-12-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-03