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New treatment option for Organ Grafts
Official title 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
What this study is testing
What is TACROLIMUS?
TACROLIMUS is an investigational medicine, being studied as a potential treatment for organ grafts.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Eplet Mismatchs \<= 14
You likely can't join if
- 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 treatment study within 1 month prior to the inclusion
- Any retransplantation and combined transplantations and also other organ previous transplantations
- History of lymphoproliferative disorders
See the full eligibility 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...
- 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)
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France
- Oslo, Norway
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France; Oslo, Norway; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.