NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation

NCT07779187 | Not Yet Recruiting DMC

• 1 other identifier: 2025-01149
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:

• Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone.
• Are the postoperative complications and outcomes different between the two groups?
• Is the quality of life of recipients different between the two groups?
• Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes. Participants will:
• Receive a kidney treated with one of the two strategies.
• Visit the clinic as per usual clinical practice for checkups and tests
• Report on their quality of life pre and post transplant
• Undergo a kidney biopsy at one year to forecast long term transplant function

Conditions

Kidney Transplant; DCD Kidney

Keywords

DCD kidneys; Normothermic Regional Perfusion (NRP); Hypothermic oxygenated perfusion; Patient reported outcomes; Kidney transplants; Randomised Control Trial; Health economic analysis

Outcome Measures

Primary Outcomes (1)

• Renal function after transplantation

  Renal function estimated by the glomerular filtration rate at 1 year after transplantation as determined by the Lund Malmö revised formula for eGFR calculated based on creatinine value

  One year after transplantation

Secondary Outcomes (22)

• 1. the iBox score at one year

  One year after transplantation

• Graft (uncensored and censored for recipient death) survival

  One year after transplant

• Patient survival

  One year after transplantation

• Delayed graft function

  7 days after transplantation

• Postoperative complications

  Three months and one year after transplant

Study Arms (2)

NRP + HMPO2

EXPERIMENTAL

DCD kidneys recovered with NRP and undergoing ex situ HMPO2 initiated at donor hospital as the intervention

Device: Ex situ hypothermic oxygenated machine preservation

NRP alone

NO INTERVENTION

DCD kidneys recovered with NRP followed by static cold storage

Interventions

Ex situ hypothermic oxygenated machine preservation DEVICE

Ex situ preservation of NRP DCD kidneys with hypothermic oxygenated machine perfusion

NRP + HMPO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donor kidneys:
• All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.
• Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)
• Recipients:
• All adult patients (\>18 yrs old) eligible for renal transplantation during study duration.
• Recipient consented for surgery, matched to a DCD kidney.

You may not qualify if:

• Donor kidneys:
• \. Kidney allocated outside of Sweden according to Scandiatransplant allocation rules.
• Recipients:
• Paediatric patients (\<18 yrs old).
• Participation in other clinical drug or medical devices trials.
• Patient subject to combined transplant of kidney + other organ.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Uppsala University Hospital: collaborator
• Skane University Hospital: collaborator
• Karolinska University: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (3)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skåne University Hospital

Malmö, Sweden

Location

Akademiska Hospital

Uppsala, Sweden

Location

Related Publications (7)

• Merani S, Urban M, Westphal SG, Dong J, Miles CD, Maskin A, Hoffman A, Langnas AN. Improved Early Post-Transplant Outcomes and Organ Use in Kidney Transplant Using Normothermic Regional Perfusion for Donation after Circulatory Death: National Experience in the US. J Am Coll Surg. 2024 Jan 1;238(1):107-118. doi: 10.1097/XCS.0000000000000880. Epub 2023 Sep 29.

  PMID: 37772721 BACKGROUND

• Hessheimer AJ, Coll E, Torres F, Ruiz P, Gastaca M, Rivas JI, Gomez M, Sanchez B, Santoyo J, Ramirez P, Parrilla P, Marin LM, Gomez-Bravo MA, Garcia-Valdecasas JC, Lopez-Monclus J, Bosca A, Lopez-Andujar R, Fundora-Suarez J, Villar J, Garcia-Sesma A, Jimenez C, Rodriguez-Laiz G, Llado L, Rodriguez JC, Barrera M, Charco R, Lopez-Baena JA, Briceno J, Pardo F, Blanco G, Pacheco D, Dominguez-Gil B, Sanchez Turrion V, Fondevila C. Normothermic regional perfusion vs. super-rapid recovery in controlled donation after circulatory death liver transplantation. J Hepatol. 2019 Apr;70(4):658-665. doi: 10.1016/j.jhep.2018.12.013. Epub 2018 Dec 22.

  PMID: 30582980 BACKGROUND

• Mirshekar-Syahkal B, Summers D, Bradbury LL, Aly M, Bardsley V, Berry M, Norris JM, Torpey N, Clatworthy MR, Bradley JA, Pettigrew GJ. Local Expansion of Donation After Circulatory Death Kidney Transplant Activity Improves Waitlisted Outcomes and Addresses Inequities of Access to Transplantation. Am J Transplant. 2017 Feb;17(2):390-400. doi: 10.1111/ajt.13968. Epub 2016 Aug 26.

  PMID: 27428662 BACKGROUND

• Jochmans I, Brat A, Davies L, Hofker HS, van de Leemkolk FEM, Leuvenink HGD, Knight SR, Pirenne J, Ploeg RJ; COMPARE Trial Collaboration and Consortium for Organ Preservation in Europe (COPE). Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial. Lancet. 2020 Nov 21;396(10263):1653-1662. doi: 10.1016/S0140-6736(20)32411-9.

  PMID: 33220737 BACKGROUND

• Moers C, Pirenne J, Paul A, Ploeg RJ; Machine Preservation Trial Study Group. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2012 Feb 23;366(8):770-1. doi: 10.1056/NEJMc1111038. No abstract available.

  PMID: 22356343 BACKGROUND

• Schutter R, Moers C, Jochmans I, Gallinat A, Paul A, Treckmann J, Pirenne J, Monbaliu D, Strelniece A, Tieken I, Vogelaar S, Rahmel A, Leuvenink HGD, Ploeg RJ; Machine Preservation Trial Study Group. Cold Perfusion vs. Static Cold Storage of Deceased-Donor Kidneys - at 10 Years. N Engl J Med. 2025 Nov 6;393(18):1859-1861. doi: 10.1056/NEJMc2406608. No abstract available.

  PMID: 41191948 BACKGROUND

• Oniscu GC, Mehew J, Butler AJ, Sutherland A, Gaurav R, Hogg R, Currie I, Jones M, Watson CJE. Improved Organ Utilization and Better Transplant Outcomes With In Situ Normothermic Regional Perfusion in Controlled Donation After Circulatory Death. Transplantation. 2023 Feb 1;107(2):438-448. doi: 10.1097/TP.0000000000004280. Epub 2023 Jan 26.

  PMID: 35993664 BACKGROUND

Study Officials

• Gabriel C Oniscu, MD, PhD, FRCS

  Karolinska University Hospital

  STUDY CHAIR

Central Study Contacts

Gabriel C Oniscu, MD, PhD, FRCS

CONTACT

+46-702768684; gabriel.oniscu@regionstockholm.se

Alexandra Thorsell

CONTACT

+46760217086; alexandra.thorsell@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Transplantation Surgery

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)