Reduced Immunosuppression for Older Adult Kidney Transplant Recipients: the RELEASE study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Consorci Mar Parc De Salut De Barcelona

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

10 Oct 2025 → ongoing

Decision date (initial)

2025-07-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 15

1. We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits in 1st year patient mortality after transplantation.
2. We aim to demonstrate that a lower immunosuppression regimen is as effective as the standard one in this population in terms of graft primary non-function.
3. We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one regarding the incidence of surgical complications within the 1st year after transplantation.
4. We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits in patient hospitalization during the 1st year after transplantation.
5. We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits in viral infections due to CMV and BK during the 1st year after transplantation.
6. We aim to demonstrate that a lower immunosuppression regimen is as effective as the standard one regarding allograft rejection.
7. We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits in patient’s quality of life.
8. We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits in patient’s frailty.
9. We aim to demonstrate that a lower immunosuppression regimen is as effective as the standard one regarding 1st year allograft survival.
10. We aim to demonstrate that a lower immunosuppression regimen is as effective as the standard one regarding 1st year allograft function.
11. We aim to demonstrate that a lower immunosuppression regimen is as effective as the standard one regarding 1st year DSA development.
12. We aim to demonstrate that a lower immunosuppression regimen is as effective as the standard one regarding estimated 5-year death-censored graft survival.
13. We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits in the proportion of patients who can maintain the immunosuppression prescribed without presenting adverse events.
14. Exploratory: We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits on markers of the net state of immunosuppression during the first year after transplantation
15. Exploratory: We aim to demonstrate that a lower immunosuppression regimen is as safe as the standard one with potential benefits on potential markers of infection during the first year after transplantation.

Conditions and MedDRA coding

End-stage renal disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Subjects must be able to understand and provide written informed consent.
2. Patients ≥ 70 years who receive their first (live or deceased donor) ABO-compatible renal transplant.
3. Patients with a pre-transplant cPRA ≤ 50%.
4. Recipient of a kidney with a cold ischemia time < 30 hours.
5. Male participants will be required to use a dual barrier method (e.g., condom plus spermicide).

Exclusion criteria 8

1. Patients who received another simultaneous solid organ transplant (liver, lung, heart, or pancreas).
2. Patients with pre-existing (historical or at the time of transplantation DSA - MFI>1000).
3. 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).
4. Subject who is anti-HIV-positive, HBsAg-positive, or anti-HCV positive.
5. Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy.
6. Subjects unable to take oral medication at the time of randomization.
7. Subjects with any medical condition at the time of randomization that, according to the investigator criteria, contraindicates the administration of the trial immunosuppression scheme.
8. Any known hypersensitivity or intolerance to study drugs or their active ingredients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite outcome of patient survival with functioning graft at 12 months in both treatment arms.

Secondary endpoints 18

1. Mortality for any reason in both treatment arms.
2. Rate of primary non-function graft in both treatment arms.
3. Incidence of surgical complications in both treatment arms.
4. Days of hospitalization for any reason in both treatment arms.
5. Number of readmissions and cause in both treatment arms.
6. Incidence of CMV and BK viremia in both treatment arms.
7. Incidence of CMV invasive disease and BK nephropathy in both treatment arms.
8. Incidence of clinical graft acute rejection through indication biopsy at any time in both treatment arms.
9. Incidence of subclinical graft rejection at 12 months through protocol biopsy in both treatment arms.
10. PREM and PROMS at randomization and at 12 months in both treatment arms.
11. Frailty (Fried and FRAIL scale) before transplant and at 12 months in both treatment arms.
12. Death-censored graft survival in both treatment arms.
13. Graft function (eGFR and proteinuria) at 12 months in both treatment arms.
14. Donor-specific antibodies (DSA) at 12 months in both treatment arms.
15. Estimated 5-y death-censored graft survival through the iBox prognostication system at 12 months in both treatment arms.
16. Rate of dropout from the initial immunosuppression scheme assigned in both treatment arms.
17. Exploratory: Torquetenovirus RT-PCR at 1, 3, 6 and 12 months in both treatment arms.
18. Exploratory: Count of CD4/CD8 lymphocyte subpopulations, C3 levels, and IgG levels at 1, 3, and 12 months in both treatment arms.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Consorci Mar Parc De Salut De Barcelona

Sponsor organisation

Consorci Mar Parc De Salut De Barcelona

Address

Passeig Maritim De La Barceloneta 25-29

City

Barcelona

Postcode

08003

Country

Spain

Scientific contact point

Organisation

Consorci Mar Parc De Salut De Barcelona

Contact name

María José

Public contact point

Organisation

Consorci Mar Parc De Salut De Barcelona

Contact name

María José

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 35 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications