PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration

NCT04693325 | Unknown DMC

• 1 other identifier: NL76344
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.

Conditions

End Stage Renal Disease

Keywords

normothermic machine perfusion; renal transplantation; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• glomerular filtration rate (GFR)

  renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

  6 months post transplantation

Secondary Outcomes (7)

• glomerular filtration rate (GFR)

  1 month post transplantation

• glomerular filtration rate (GFR)

  3 months post transplantation

• primary non-function

  6 months post transplantation

• delayed graft function (DGF)

  6 months post transplantation

• patient and graft survival

  6 months post transplantation

Study Arms (1)

Prolonged normothermic machina perfusion

EXPERIMENTAL

Eligible and consenting patients who will receive a donor kidney will be included for participation in this study. Current practice is to preserve donor kidneys on hypothermic machine perfusion (HMP). In this study, donor kidneys (n=18) will be taken off the HMP after arrival in the transplant center. These will then be perfused with oxygenated perfusate using the NMP device following an optimised NMP protocol.

Procedure: Prolonged normothermic machine perfusion

Interventions

Prolonged normothermic machine perfusion PROCEDURE

First, a cohort of DCD kidneys (n=6) will be subjected to 1 hour of NMP and subsequently transplanted \[NMP1\]. Before extending the duration, secondary endpoints will be evaluated. Thereafter, the duration of NMP will be prolonged to 3 hours (n=6) \[PNMP3\] and consequently 6 hours (n=6) \[PNMP6\].

Prolonged normothermic machina perfusion

Eligibility Criteria

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

You may qualify if:

• Patients undergoing 1st or 2nd kidney transplant
• Patients undergoing a kidney transplantation from DCD Maastricht III \& V
• Transplant recipients aged ≥ 18 years
• Written informed consent

You may not qualify if:

• Patients undergoing 3rd or subsequent kidney transplant
• Patients undergoing a kidney transplantation from DCD Maastricht I, II \& IV
• Transplant recipients aged \< 18 years
• Patients receiving multi-organ transplants
• ABO/HLA incompatible transplants
• Highly sensitized patients with a panel-reactive antibody (PRA) ≥85%
• Kidneys with CIT \> 12 hrs at the point of arrival at transplant centre
• Kidneys with complex vascular anatomy (≥3 arteries, artery which cannot be can-nulated or attached to the patch holder)
• Kidneys explanted from a donor on normothermic regional perfusion

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

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 Officials

• Ian PJ Alwayn, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asel Arykbaeva

CONTACT

+31657216416; a.s.arykbaeva@lumc.nl

Dorottya K De Vries, MD PhD

CONTACT

d.k.de_vries@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: January 5, 2021
• Study Start: December 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)