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Reduced Immunosuppression for Older Adult Kidney Transplant Recipients: the RELEASE study.
EU CTIS ID: 2025-520535-16-00
What this study is testing
We aim to demonstrate that a lower immunosuppression regimen is as effective as the standard one in this population regarding patient and graft survival during the 1st year after transplantation.
- Therapeutic use (Phase IV)
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
- Subjects must be able to understand and provide written informed consent.
- Patients ≥ 70 years who receive their first (live or deceased donor) ABO-compatible renal transplant.
- Patients with a pre-transplant cPRA ≤ 50%.
- Recipient of a kidney with a cold ischemia time < 30 hours.
- Male participants will be required to use a dual barrier method (e.g., condom plus spermicide).
You likely can't join if
- Patients who received another simultaneous solid organ transplant (liver, lung, heart, or pancreas).
- Patients with pre-existing (historical or at the time of transplantation DSA - MFI>1000).
- Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
- Subject who is anti-HIV-positive, HBsAg-positive, or anti-HCV positive.
- Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy.
- Subjects unable to take oral medication at the time of randomization.
See the full eligibility criteria
- Subjects must be able to understand and provide written informed consent.
- Patients ≥ 70 years who receive their first (live or deceased donor) ABO-compatible renal transplant.
- Patients with a pre-transplant cPRA ≤ 50%.
- Recipient of a kidney with a cold ischemia time < 30 hours.
- Male participants will be required to use a dual barrier method (e.g., condom plus spermicide).
- Patients who received another simultaneous solid organ transplant (liver, lung, heart, or pancreas).
- Patients with pre-existing (historical or at the time of transplantation DSA - MFI>1000).
- Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
- Subject who is anti-HIV-positive, HBsAg-positive, or anti-HCV positive.
- Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy.
- Subjects unable to take oral medication at the time of randomization.
- Subjects with any medical condition at the time of randomization that, according to the investigator criteria, contraindicates the administration of the trial immunosuppression scheme.
- Any known hypersensitivity or intolerance to study drugs or their active ingredients.
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. 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.