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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACROLIMUS | Drug | TACROLIMUS 2-3.5 ng/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali GIRAL | Contact | +33240087443 | magali.giral@chu-nantes.fr | |
| Sonia Brinet | Contact | +33253526126 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de NANTES | Recruiting | Nantes | 44000 | France |
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| 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 |
| Prevalence of metabolic disorders: post-transplant diabetes mellitus (PTDM), dyslipidaemia and hypertension at end of study | Month 18 |
| Treatment adherence consisting in monitoring immunosuppression adherence using Trackyourmed® to monitor individual variability tacrolimus intake | 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. | Month 3, Month 6, Month 9, Month 12, Month15 and Month18 |
| Oslo University Hospital | Not yet recruiting | Oslo | Norway |
|
| Hospital Universitari Vall d'Hebron | Not yet recruiting | Barcelona | Spain |
|
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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