AGORAC
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
Sponsor study identifier
interventional
300
3 countries
3
Study Start
December 10, 2024
Actual (reported)Primary Completion
June 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2024
Actual (reported)February 1, 2024
Actual (reported)December 10, 2024
Actual (reported)June 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus
Improvement will be assessed by measured glomerular filtration rate (mGFR) iohexol clearance.
Month 18
Incidence of biopsy-proven acute rejection (BPAR) according to the 2017 Banff classification (including borderline lesions)
Month 18
Type, severity and treatment of biopsy-proven acute rejection ( BPAR)
Month 18
Appearance of de novo donor-specific alloantibody (DSA) (4 digits and MFI treshold >500)
Month 18
Appearance or worsening of histological lesions of interstitial fibrosis and inflammatory tubular atrophy (IFTA) of study biopsy by considering that only patients with normal histology or with an IFTA-1 or 2will be randomized
Month 18
Prevalence of death, and graft loss (dialysis start or retransplantation) at end of study
Month 18
Ultra-low TACROLIMUS (TAC) arm based on MMF/MPA (Mycophenolate Mofetil/ Mycophénolic Acid) with or without CS (Cortico Steroid ) and TACROLIMUS to achieve 2-3.5 ng/ml trough levels during all the duration of the study.
SOC-TAC arm based on MMF/MPA with or without CS and TACROLIMUS to achieve 4 and 7 ng/ml trough levels during all the duration of the study
TACROLIMUS 2-3.5 ng/ml
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
PROGRAF 0,5 mg capsule
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
CellCept 500 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
CORTANCYL 1 mg, comprimé
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
Advagraf 0.5 mg prolonged-release hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE CAPSULE, HARD
View registry recordFormulated product
Omnipaque 300 mg I/ml solution injectable
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
PROGRAF 0,5 mg capsule
Named ingredient: Tacrolimus
View registry recordCellCept 500 mg film-coated tablets
Named ingredient: Mycophenolate mofetil
View registry recordCORTANCYL 1 mg, comprimé
Named ingredient: Prednisone
View registry recordAdvagraf 0.5 mg prolonged-release hard capsules
Named ingredient: Tacrolimus
View registry recordOmnipaque 300 mg I/ml solution injectable
Named ingredient: Iohexol
View registry recordMyfortic 180 mg comprimés gastro-résistants
Named ingredient: Mycophenolic acid
View registry recordCHU de NANTES
Nantes, 44000, France
Oslo University Hospital
Oslo, Norway
Hospital Universitari Vall d'Hebron
Barcelona, Spain
First Submitted
January 23, 2024
First Posted
February 1, 2024
Study Start
December 10, 2024
Actual (reported)Primary Completion
June 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
Formulated product
Myfortic 180 mg comprimés gastro-résistants
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
GASTRO-RESISTANT TABLET
View registry recordContact the study team to confirm eligibility.
Study Completion
December 10, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 3, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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