Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Reduced Immunosuppression Therapy Trial for Elderly Kidney Transplant Recipients with End-Stage Renal Disease

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The RELEASE study is a clinical trial examining reduced immunosuppression regimens for older adult kidney transplant recipients with end-stage renal disease. This is a serious condition where the kidneys no longer function well enough to meet the body's needs, requiring either dialysis or kidney transplantation. The study compares a lower immunosuppression regimen to the standard treatment approach in people aged 70 and older who receive their first kidney transplant.

Immunosuppression medications are drugs that reduce the activity of the immune system to prevent rejection of the transplanted kidney. However, these medications can have significant side effects, particularly in older adults. The purpose of this study is to determine if a reduced immunosuppression regimen can be as effective as the standard approach in terms of patient survival and transplant function.

Participants in this study will be randomly assigned to either the standard or reduced immunosuppression treatment group and followed for 12 months after their kidney transplant. During this time, researchers will monitor various outcomes including patient survival with functioning graft, complications, infections such as CMV (cytomegalovirus) and BK virus, and kidney function. The study will also assess quality of life measures and frailty before transplant and at the end of the 12-month period.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study Duration

    You will participate in this kidney transplant study for a total of 12 months after receiving your kidney transplant.

    During this time, your progress will be closely monitored to evaluate how well a reduced immunosuppression regimen works compared to the standard regimen for kidney transplant recipients aged 70 and older.

  2. Step 2

    Study Assignment

    After joining the study, you will be randomly assigned to one of two treatment groups - either the standard immunosuppression regimen or a reduced immunosuppression regimen.

    This assignment is random, similar to flipping a coin, and determines which medication plan you will follow throughout the study.

  3. Step 3

    Medication Regimen

    Depending on your assigned group, you will receive a combination of immunosuppressive medications which may include tacrolimus, prednisone, methylprednisolone, basiliximab, and/or mycophenolate sodium.

    These medications help prevent your body from rejecting the transplanted kidney by suppressing your immune system.

    The medication dosages and frequencies will be determined by your transplant team based on your assigned study group.

    You will need to take these medications as prescribed throughout the 12-month study period.

  4. Step 4

    Follow-up Visits

    You will have regular follow-up visits throughout the 12-month study period.

    During these visits, your transplant team will monitor your health and the function of your transplanted kidney.

    Blood tests will be performed at 1, 3, 6, and 12 months to check for viruses and to measure various immune system components.

    You will also undergo testing for donor-specific antibodies (proteins that might attack your new kidney) at the 12-month mark.

  5. Step 5

    Kidney Biopsy

    At the 12-month point, you will undergo a protocol kidney biopsy to check for any signs of subclinical rejection (rejection that occurs without obvious symptoms).

    Additional biopsies may be performed if there are signs that suggest your body might be rejecting the transplanted kidney.

  6. Step 6

    Health Status Assessment

    Before your transplant and again at the 12-month mark, your frailty level will be assessed using specific scales (Fried and FRAIL scale).

    You will also complete questionnaires about your experience as a patient and health outcomes at the beginning and end of the study.

  7. Step 7

    Monitoring for Complications

    Throughout the study, you will be monitored for any complications including CMV (cytomegalovirus) and BK virus infections, which can occur more frequently in transplant patients due to suppressed immune systems.

    Your kidney function will be regularly assessed through blood and urine tests that measure eGFR (estimated glomerular filtration rate, which shows how well your kidneys are filtering) and proteinuria (protein in urine).

  8. Step 8

    Study Completion

    At the end of the 12-month period, a final assessment will be conducted to evaluate the success of your transplant and the effectiveness of your immunosuppression regimen.

    The study team will use a system called iBox to estimate your 5-year death-censored graft survival (how likely your transplanted kidney will continue to function for 5 years).

Who can join the trial?

8 criteria

  • You must have end-stage renal disease (kidneys that have permanently failed to work)
  • You must be 70 years of age or older
  • This must be your first kidney transplant (either from a living or deceased donor)
  • Your blood type must be compatible with the donor kidney
  • Your cPRA level must be 50% or less (cPRA measures antibodies in your blood that might react against donor tissues)
  • The kidney being transplanted must have been preserved for less than 30 hours since removal from the donor
  • Male participants must agree to use dual barrier contraception (such as condom plus spermicide)
  • You must be able to understand and sign an informed consent document

Who cannot join the trial?

10 criteria

  • You have severe mental health conditions that might affect your ability to understand the study or provide informed consent.
  • You have a history of malignancy (cancer) in the last 5 years, except for certain skin cancers that have been completely removed.
  • You have tested positive for HIV, hepatitis B, or hepatitis C.
  • You've had a previous organ transplant that failed within the first year.
  • You're receiving a transplant from a donor after cardiac death.
  • You're participating in another clinical trial with an experimental treatment.
  • You're pregnant or breastfeeding, or if you're able to become pregnant and not willing to use effective birth control during the study.
  • You have an active infection that requires treatment.
  • You have a medical condition that, in the opinion of the study doctor, would make it unsafe for you to participate.
  • You're unable or unwilling to follow the study procedures or attend required follow-up visits.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

The medications involved in the trial are: Immunosuppression regimen - These are medications that reduce the activity of your immune system. In kidney transplantation, immunosuppressants are essential to prevent your body from rejecting the new kidney. The study is comparing a standard immunosuppression regimen with a reduced (lower) immunosuppression regimen specifically for older adults who receive kidney transplants.

What is already known about the treatment

Reduced Immunosuppression Regimen - This refers to a decreased dose or intensity of medications used to suppress the immune system in kidney transplant recipients, especially in older adults. This approach is currently being investigated in clinical trials, like the RELEASE study, to determine if it can provide adequate protection against organ rejection while potentially reducing side effects. Reduced immunosuppression works by partially inhibiting the immune response that would normally attack the transplanted kidney, but at lower levels than standard protocols. It falls under the pharmacological classification of immunosuppressive therapy, which is essential for preventing transplant rejection after kidney transplantation.

Investigated diseases

End-stage renal disease – A condition where the kidneys permanently fail to work at a level needed for day-to-day life. It occurs when chronic kidney disease progresses to the point where kidney function is less than 15% of normal. The kidneys can no longer filter waste and excess fluids from the blood, which then build up in the body. Patients experience symptoms such as fatigue, swelling in legs and ankles, itching, muscle cramps, and changes in urination patterns. Without functioning kidneys, toxic substances accumulate, leading to complications affecting nearly all body systems.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-520535-16-00Protocol codeRELEASEEstimated enrolment270 patientsSponsorConsorci Mar Parc De Salut De Barcelona

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.