BridgeMD
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
EU CTIS ID: 2022-502624-44-00
What this study is testing
The primary objective 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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient
- Patient (of childbearing age) with effective contraception (sexual abstinence, use of a condom with spermicide, contraceptive sponge, uterine diaphragm, hormonal contraception, or intrauterine contraceptive device) The contraception should be used throughout the entire study period.
- Eplet Mismatchs <= 14
- Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS +/- Corticosteroid (CS)
- First kidney transplantation
- Living or a brain death or deceased donor (Maastricht 3)
You likely can't join if
- Deceased donor maastricht 2
- 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
See the full eligibility criteria
- Adult patient
- Patient (of childbearing age) with effective contraception (sexual abstinence, use of a condom with spermicide, contraceptive sponge, uterine diaphragm, hormonal contraception, or intrauterine contraceptive device) The contraception should be used throughout the entire study period.
- Eplet Mismatchs <= 14
- Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS +/- Corticosteroid (CS)
- First kidney transplantation
- Living or a brain death or deceased donor (Maastricht 3)
- Compatible for ABO group with the donor
- One year post kidney transplantation ( between 350 et 515 days after the transplantation)
- cPRA (ou TGI <20%) 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
- Normal or IFTA 1-2 histology on one-year surveillance biopsy or within the month before the V1 visit
- Patient insured under a health insurance scheme, according to national regulation.
- Deceased donor maastricht 2
- 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
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.