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Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

NCT ID: NCT05782543

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2028-05-01

Brief Summary

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The REWARM study is a randomized controlled clinical efficacy study, with primary outcome renal function 12 months after transplantation of kidneys recovered from deceased donors aged 50 years or older. Prior to transplantation, kidney grafts in the intervention group will receive 6 hours of NMP, following standard HMP and kidneys in the control group will only receive standard treatment, being HMP. It is a multi-center trial. Given the total annual 50+ deceased donor kidney transplantation volume of the three participating transplant centers combined, inclusions in the study are expected to last 2.5-3 years, aiming for a total of 120 patients in each of the two arms (240 patients total).

Detailed Description

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Conditions

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Kidney Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hypothermic machine perfusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Normothermic machine perfusion

Group Type ACTIVE_COMPARATOR

Normothermic machine perfusion

Intervention Type PROCEDURE

To determine whether a 4-6 hour period of normothermic machine perfusion, following standard hypothermic machine perfusion, results in better graft function after transplantation, compared to hypothermic machine perfusion preservation alone of kidneys recovered from deceased donors aged 50 years or older

Interventions

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Normothermic machine perfusion

To determine whether a 4-6 hour period of normothermic machine perfusion, following standard hypothermic machine perfusion, results in better graft function after transplantation, compared to hypothermic machine perfusion preservation alone of kidneys recovered from deceased donors aged 50 years or older

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients receiving their first or second kidney transplant;
* Patients receiving a graft from a ≥ 50-year-old donor;
* Patients receiving a graft from a DCD or DBD donor;
* Patients receiving a kidney transplant in the UMCG, the Erasmus MC, or the LUMC;
* Patients receiving a graft stored on HMP;
* Patients ≥ 18 years of age;
* Patients having provided written informed consent.

Exclusion Criteria

* Patients receiving their third or subsequent kidney transplant;
* Patients receiving a graft from a donor \< 50 years;
* Patients receiving a graft not stored on HMP;
* Patients receiving a graft from a donor that underwent normothermic regional perfusion (NRP);
* Patients receiving a kidney transplant in another center than the UMCG, Erasmus MC, or LUMC;
* Patients receiving a multi-organ transplantation;
* Patients receiving a kidney with complex arterial anatomy (3 or more arteries);
* Recipients \< 18 years of age.
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status NOT_YET_RECRUITING

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Cyril Moers, MD, PhD

Role: CONTACT

Phone: 0619602619

Email: [email protected]

Kirsten Ma, PhD

Role: CONTACT

Phone: 0625651635

Email: [email protected]

Facility Contacts

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Cyril Moers, MD, PHD

Role: primary

Dorottya de Vries, MD, PhD

Role: primary

Robert Minnee, MD, PhD

Role: primary

References

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Longchamp A, Markmann JF. Kidney Preservation Strategies to Improve Transplant Outcomes. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1628-1630. doi: 10.2215/CJN.0000000000000212. Epub 2023 May 23. No abstract available.

Reference Type DERIVED
PMID: 37219010 (View on PubMed)

Other Identifiers

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15911

Identifier Type: -

Identifier Source: org_study_id