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PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration

NCT04693325 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-01-03

No results posted yet for this study

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

Interventions

PROCEDURE

Prolonged normothermic machine perfusion

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) \[PNMP6\].

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Ian PJ Alwayn, MD PhD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-07-31
Completion
2023-01-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693325 on ClinicalTrials.gov