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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Fundacio Puigvert	Barcelona	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña	A Coruna Galicia	Spain
Hmmzotwr Ugjwremxkqghj Hbvrbfae Tqibp y Ppypwj Ikfvuqin Cwncpz dzhotnvxwkmncdyjx (bbgb	Badalona	Spain
Hkmzyzoj Vszd dryjvcnp	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.07.2025

Trial locations

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.

Investigated diseases:

End stage renal disease

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 ID:

2025-520535-16-00

Protocol code:

RELEASE

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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