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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermic machine perfusion | No Intervention | ||
| Normothermic machine perfusion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and graft survival | Patient and graft survival up to 12 months after transplantation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cyril Moers, MD, PhD | Contact | 0619602619 | c.moers@umcg.nl | |
| Kirsten Ma, PhD | Contact | 0625651635 | k.f.ma@umcg.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Recruiting | Groningen | Provincie Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37219010 | Derived | 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. |
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|
| 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 | 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. | 12 months |
| Number of participants with biopsy-proven acute rejection | 12 monts |
| estimated Glomerular Filtration Rate | eGFR at day 7, and 1, 3, 6 and 12 months after transplantation | 12 months |
| (serious) adverse events | Number of adverse (device) events and serious adverse (device) events | 12 months |
| Postoperative complications | 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 | 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 | 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 | 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 | 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 | 12 months |
| Leiden University Medical Center | Not yet recruiting | Leiden | Netherlands |
|
| Erasmus Medical Center | Recruiting | Rotterdam | Netherlands |
|