NCT05782543

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Dec 2024May 2028

First Submitted

Initial submission to the registry

February 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

February 7, 2023

Last Update Submit

December 10, 2025

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

  • Graft function at twelve months after transplantation

    The primary endpoint of this study is graft function at twelve months after transplantation, defined as the estimated glomerular filtration rate (eGFR).

    12 months

Secondary Outcomes (13)

  • Patient and graft survival

    12 months

  • Occurence of delayed graft function (DGF) in the first 7 days after transplantation

    7 days

  • Duration of delayed graft function (DGF) in the first 7 days after transplantation

    7 days

  • Number of participants with primary non-function (PNF)

    12 months

  • Number of participants with biopsy-proven acute rejection

    12 monts

  • +8 more secondary outcomes

Study Arms (2)

Hypothermic machine perfusion

NO INTERVENTION

Normothermic machine perfusion

ACTIVE COMPARATOR
Procedure: Normothermic machine perfusion

Interventions

Normothermic machine perfusionPROCEDURE

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

Normothermic machine perfusion

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, Netherlands

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37219010DERIVED

Central Study Contacts

Cyril Moers, MD, PhD

CONTACT

0619602619c.moers@umcg.nl

Kirsten Ma, PhD

CONTACT

0625651635k.f.ma@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

March 23, 2023

Study Start

December 15, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)