Organ GraftsPhase 3AGORACNCT06235892
Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
A Phase 3 study testing TACROLIMUS in people with Organ Grafts, run by Nantes University Hospital at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Grafts
- What is being tested?
- TACROLIMUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 10 Dec 2024to 10 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Sonia Brinet contact
3 sites in 3 countries
Norway1 site, 1 recruiting
- Not yet recruiting
Oslo University Hospital
Oslo
Kristian Heldal
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona
Oriol BESTARD
About this study
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
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.
- Conditions
- Organ Grafts
- Being tested
- TACROLIMUS
- Keywords
- Tacrolimus minimization, kidney transplant, AGORA Algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACROLIMUSDrug
TACROLIMUS 2-3.5 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Ultra-low TACROLIMUS arm | Experimental | 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. Receives: Drug: TACROLIMUS |
| SOC ( Standard of care)-TACROLIMUS arm | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 18
Secondary outcomes (8)
Incidence of biopsy-proven acute rejection (BPAR) according to the 2017 Banff classification (including borderline lesions)
Measured: Month 18
Type, severity and treatment of biopsy-proven acute rejection ( BPAR)
Measured: Month 18
Appearance of de novo donor-specific alloantibody (DSA) (4 digits and MFI treshold >500)
Measured: 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
Measured: Month 18
Prevalence of death, and graft loss (dialysis start or retransplantation) at end of study
Measured: Month 18
Prevalence of metabolic disorders: post-transplant diabetes mellitus (PTDM), dyslipidaemia and hypertension at end of study
Measured: Month 18
Treatment adherence consisting in monitoring immunosuppression adherence using Trackyourmed® to monitor individual variability tacrolimus intake
Measured: Month 18
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
There is two score in the EQ-5D-5L The first one is the descriptive system: Minimum value:5 ( no problems on any dimension) Maximum value: 25 ( extreme problems on all dimensions)
The second score is EQ VAS (EuroQol vertical visual analogue scale) score. It is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.
Measured: Month 3, Month 6, Month 9, Month 12, Month15 and Month18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start10 Dec 2024
- Primary completion10 Jun 2028 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ GraftsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235892
- Sponsor's protocol ID
- RC22_0525
- Acronym
- AGORAC
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06235892
- Acronym / sponsor ID
- AGORAC / RC22_0525
- Conditions
- Organ Grafts
- Keywords
- Tacrolimus minimization, kidney transplant, AGORA Algorithm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Jun 2028 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-low TACROLIMUS arm | Experimental | Drug: TACROLIMUSUltra-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 ( Standard of care)-TACROLIMUS arm | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACROLIMUSTACROLIMUS 2-3.5 ng/ml | Drug | Ultra-low TACROLIMUS arm |
Primary outcome
Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus
Time frame: Month 18
Improvement will be assessed by measured glomerular filtration rate (mGFR) iohexol clearance.
8 secondary outcomes
Incidence of biopsy-proven acute rejection (BPAR) according to the 2017 Banff classification (including borderline lesions)
Time frame: Month 18
Type, severity and treatment of biopsy-proven acute rejection ( BPAR)
Time frame: Month 18
Appearance of de novo donor-specific alloantibody (DSA) (4 digits and MFI treshold >500)
Time frame: 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
Time frame: Month 18
Prevalence of death, and graft loss (dialysis start or retransplantation) at end of study
Time frame: Month 18
Prevalence of metabolic disorders: post-transplant diabetes mellitus (PTDM), dyslipidaemia and hypertension at end of study
Time frame: Month 18
Treatment adherence consisting in monitoring immunosuppression adherence using Trackyourmed® to monitor individual variability tacrolimus intake
Time frame: Month 18
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
Time frame: Month 3, Month 6, Month 9, Month 12, Month15 and Month18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonia Brinet contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TACROLIMUS in people with Organ Grafts, run by Nantes University Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Norway, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali GIRAL (+33240087443, magali.giral@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus (time frame: Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.