Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?

NCT04882254 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: APOLLO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.

Conditions

Kidney Transplant Failure; Chronic Kidney Failure

Keywords

Normothermic kidney machine perfusion

Outcome Measures

Primary Outcomes (1)

• Number of patients with immediate graft function

  Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.

  3 months

Secondary Outcomes (5)

• Duration of delayed graft function

  3 months

• estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant

  1 year

• Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant

  1 year

• all-cause and death-censored graft survival up to 5 years

  5 years

• patient survival up to 5 years

  5 years

Study Arms (2)

Normothermic machine perfusion

EXPERIMENTAL

Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate.

Procedure: Normothermic machine perfusion

Standard-of-care

NO INTERVENTION

Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands.

Interventions

Normothermic machine perfusion PROCEDURE

Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.

Normothermic machine perfusion

Eligibility Criteria

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

You may qualify if:

• kidney-only transplant
• renal replacement therapy at time of transplant
• receiving standard immunosuppression regimen post-transplant.
• Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.

You may not qualify if:

• pre-emptive at time of transplant
• receive a multi-organ or dual kidney transplant
• age donor or recipient below 18 years
• Maastricht type I and II DCD
• donor kidneys preserved on static cold storage (SCS)
• kidneys retrieved after normothermic regional perfusion (NRP)
• Recipient virtual panel reactive antibodies ≥85%
• Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC Transplant Institute

Rotterdam, 3015GD, Netherlands

Location

Related Publications (3)

• Lin H, Bousnina K, Slagter JS, Fang Y, Cristoferi I, Garrelds IM, Danser AHJ, Reinders MEJ, Minnee RC, Hoogduijn MJ. (Pro)renin, Erythropoietin, Vitamin D and Urodilatin Release From Human Donor Kidneys During Normothermic Machine Perfusion: Predictors of Early Post-Transplant Outcome? Clin Transplant. 2025 May;39(5):e70163. doi: 10.1111/ctr.70163.

  PMID: 40278798 DERIVED

• Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.

  PMID: 38979743 DERIVED

• Rijkse E, Bouari S, Kimenai HJAN, de Jonge J, de Bruin RWF, Slagter JS, van den Hoogen MWF, IJzermans JNM, Hoogduijn MJ, Minnee RC. Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial. Int J Surg Protoc. 2021 Oct 6;25(1):227-237. doi: 10.29337/ijsp.165. eCollection 2021.

  PMID: 34708171 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transplant surgeon

Model Details: 1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: May 1, 2021
• Primary Completion: May 6, 2024
• Study Completion: May 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)