Comparing two methods for preserving kidneys before transplantation
Normothermic Machine Perfusion (NMP) Compared to Static Cold Storage (SCS) in Donation After Brain Death (DBD) Kidney Transplantation; a Prospective Multicenter Randomized Controlled Trial (NMP-DBD)
This study is testing if a new way of keeping kidneys alive before transplanting them can help patients waiting for a kidney from a donor who might not be a perfect match.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 4 sites (Berlin and 3 other locations) |
| Trial ID | NCT05031052 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares normothermic machine perfusion (NMP) with static cold storage (SCS) for preserving kidneys from extended criteria donors prior to transplantation. The study aims to evaluate whether NMP can reduce complications and improve outcomes for patients receiving these marginal organs. By utilizing NMP, the trial seeks to optimize kidney function and minimize ischemia-reperfusion injury, which is a common issue with traditional preservation methods. Participants will be patients aged 18 and older who are on the waiting list for kidney transplantation and are receiving an extended criteria donor allograft.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older suffering from end-stage kidney disease who are listed for kidney transplantation and are receiving an extended criteria donor allograft.
Not a fit: Patients who have received living donor kidney transplants or those with previous kidney transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better kidney function and fewer complications for patients receiving transplants from extended criteria donors.
How similar studies have performed: Other studies have shown promising results with machine perfusion techniques, suggesting potential benefits over traditional preservation methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Patients 18 years or older * Patients suffering from end-stage kidney disease / kidney failure * Listed for kidney transplantation * Receiving ECD-allograft Exclusion Criteria: * Recipients of living donor kidney transplants * Previous kidney transplantation * Combined transplantations (liver-kidney, kidney-pancreas, etc.) * Participation in other kidney related trials * Exposure to an investigational drug within 30 days prior to inclusion * Unwilling or unable to follow the procedures outlined in the protocol * Mentally or legally incapacitated
Where this trial is running
Berlin and 3 other locations
- Charité Universitaetsmedizin Berlin, Campus Mitte | Campus Virchow-Klinikum — Berlin, Germany (Recruiting)
- Medizinische Hochschule Hannover (MHH), Department of Surgery and Transplantation — Hannover, Germany (Not_yet_recruiting)
- University Hospital Heidelberg, Department of Surgery and Transplantation — Heidelberg, Germany (Not_yet_recruiting)
- Ludwig-Maximilian's University, Campus Grosshadern, Department of General, Visceral, and Transplant Surgery — Munich, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Georg Lurje, M.D.
- Email: georg.lurje@charite.de
- Phone: +4930450652339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.