Kidney Transplant; ComplicationsREWARMNCT05782543
Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion
A study testing Normothermic machine perfusion in people with Kidney Transplant; Complications, run by University Medical Center Groningen at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Normothermic machine perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesNetherlands
- Study dates
- 15 Dec 2024to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen
Cyril Moers, MD, PHD, +31619602619, c.moers@umcg.nl
- Not yet recruiting
Leiden University Medical Center
Leiden
Dorottya de Vries, MD, PhD, +31715269111
- Recruiting
Erasmus Medical Center
Rotterdam
Robert Minnee, MD, PhD, +31107040704
About this study
Official title: Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion - The REWARM Study
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).
- Conditions
- Kidney Transplant; Complications
- Being tested
- Normothermic machine perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic machine perfusionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Hypothermic machine perfusion | No intervention | Not described |
| Normothermic machine perfusion | Active comparator | Not described Receives: Procedure: Normothermic machine perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (13)
Patient and graft survival
Patient and graft survival up to 12 months after transplantation
Measured: 12 months
Occurence of delayed graft function (DGF) in the first 7 days after transplantation
DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant
Measured: 7 days
Duration of delayed graft function (DGF) in the first 7 days after transplantation
DGF defined as dialysis requirement in the first week after transplantation, excluding dialysis for one-time hyperkaliemia in the first two days post-transplant
Measured: 7 days
Number of participants with primary non-function (PNF)
Incidence of primary non-function (PNF) defined as a permanent lack of graft function starting after transplantation.
Measured: 12 months
Number of participants with biopsy-proven acute rejection
Measured: 12 monts
estimated Glomerular Filtration Rate
eGFR at day 7, and 1, 3, 6 and 12 months after transplantation
Measured: 12 months
(serious) adverse events
Number of adverse (device) events and serious adverse (device) events
Measured: 12 months
Postoperative complications
Measured: 12 months
The mean serum concentration of creatinine in umol/L for each study arm
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
Measured: 12 months
The mean serum concentration of urea in umol/L for each study arm
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
Measured: 12 months
The mean serum concentration of sodium in umol/L for each study arm
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
Measured: 12 months
The mean serum concentration of potassium in umol/L for each study arm
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
Measured: 12 months
The mean serum concentration of proteins in umol/L for each study arm
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start15 Dec 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782543
- Sponsor's protocol ID
- 15911
- Acronym
- REWARM
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37219010
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion - The REWARM Study
- ClinicalTrials.gov ID
- NCT05782543
- Acronym / sponsor ID
- REWARM / 15911
- Conditions
- Kidney Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermic machine perfusion | No intervention | – |
| Normothermic machine perfusion | Active comparator | Procedure: Normothermic machine perfusion |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normothermic machine perfusionTo 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 | Procedure or surgery | Normothermic machine perfusion |
Primary outcome
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).
13 secondary outcomes
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
The mean serum concentration of proteins in umol/L for each study arm
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 37219010Longchamp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normothermic machine perfusion in people with Kidney Transplant; Complications, run by University Medical Center Groningen at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyril Moers, MD, PhD (0619602619, c.moers@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft function at twelve months after transplantation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.