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Recruiting NCT05782543

Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

No phase Interventional Kidney Transplant; Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Normothermic machine perfusion.
Who it may be relevant to
Registry conditions: Kidney Transplant; Complications. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • Procedure 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

Primary outcome measures

  • Graft function at twelve months after transplantation [Time frame: 12 months]
Secondary outcome measures (12)
  • Patient and graft survival [Time frame: 12 months]
  • Occurence of delayed graft function (DGF) in the first 7 days after transplantation [Time frame: 7 days]
  • Duration of delayed graft function (DGF) in the first 7 days after transplantation [Time frame: 7 days]
  • Number of participants with primary non-function (PNF) [Time frame: 12 months]
  • Number of participants with biopsy-proven acute rejection [Time frame: 12 monts]
  • estimated Glomerular Filtration Rate [Time frame: 12 months]
  • (serious) adverse events [Time frame: 12 months]
  • Postoperative complications [Time frame: 12 months]
  • The mean serum concentration of creatinine in umol/L for each study arm [Time frame: 12 months]
  • The mean serum concentration of urea in umol/L for each study arm [Time frame: 12 months]
  • The mean serum concentration of sodium in umol/L for each study arm [Time frame: 12 months]
  • The mean serum concentration of potassium in umol/L for each study arm [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Netherlands · 3 centers
  • University Medical Center Groningen — Groningen
  • Leiden University Medical Center — Leiden
  • Erasmus Medical Center — Rotterdam

Publications

  • 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 37219010

Identifiers

NCT: NCT05782543 · 15911

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗