Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion

Kidney Transplant; Complications Clinical Trial

— REWARM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05782543
• Other study ID #: 15911
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: March 2023
• Source: University Medical Center Groningen
• Contact: Cyril Moers, MD, PhD
• Phone: 0619602619
• Email: c.moers[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The REWARM study is an open label, randomized controlled clinical efficacy study, with primary outcome renal function 6 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 4-6 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 140 patients in each of the two arms (280 patients total).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient and graft survival	Patient and graft survival up to 12 months after transplantation	12 months
Secondary	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	7 days
Secondary	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
Secondary	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
Secondary	Number of participants with biopsy-proven acute rejection		12 monts
Secondary	estimated Glomerular Filtration Rate	eGFR at day 7, and 1, 3 and 6 months after transplantation	6 months
Secondary	(serious) adverse events	Number of adverse (device) events and serious adverse (device) events	12 months
Secondary	Postoperative complications		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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