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NCT Number: NCT05782543

Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

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).

Recruiting

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Key information

Conditions

Kidney Transplant; Complications

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen, Groningen, Provincie Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normothermic machine perfusion

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

Primary outcomes

  1. Graft function at twelve months after transplantation

    Time frame: 12 months

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

Secondary outcomes

  1. Patient and graft survival

    Time frame: 12 months

    Patient and graft survival up to 12 months after transplantation

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

    Time frame: 7 days

    DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant

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

    Time frame: 7 days

    DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant

  4. Number of participants with primary non-function (PNF)

    Time frame: 12 months

    Incidence of primary non-function (PNF) defined as a permanent lack of graft function starting after transplantation.

  5. Number of participants with biopsy-proven acute rejection

    Time frame: 12 monts

  6. estimated Glomerular Filtration Rate

    Time frame: 12 months

    eGFR at day 7, and 1, 3, 6 and 12 months after transplantation

  7. (serious) adverse events

    Time frame: 12 months

    Number of adverse (device) events and serious adverse (device) events

  8. Postoperative complications

    Time frame: 12 months

  9. The mean serum concentration of creatinine in umol/L for each study arm

    Time frame: 12 months

    Biochemical analysis of graft function with patient serum and urine levels of creatinine at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation

  10. The mean serum concentration of urea in umol/L for each study arm

    Time frame: 12 months

    Biochemical analysis of graft function with patient serum and urine levels of urea at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation

  11. The mean serum concentration of sodium in umol/L for each study arm

    Time frame: 12 months

    Biochemical analysis of graft function with patient serum and urine levels of sodium at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation

  12. The mean serum concentration of potassium in umol/L for each study arm

    Time frame: 12 months

    Biochemical analysis of graft function with patient serum and urine levels of potassium at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation

  13. The mean serum concentration of proteins in umol/L for each study arm

    Time frame: 12 months

    Biochemical analysis of graft function with patient serum and urine levels of protein at postoperative day 0-7, and 1, 3, 6 and 12 months after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Cyril Moers, MD, PhD

CONTACT

[email protected]

0619602619

Kirsten Ma, PhD

CONTACT

[email protected]

0625651635

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion - The REWARM Study

Acronym: REWARM

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 23, 2023
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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