A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys from donors older than 50 years of age and donated after circulatory death.

Phase 3

Completed

• Conditions: Endstage renal failure; Renal insufficiency; 10029149; 10038365

• Registration Number: NL-OMON44723
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 93

Inclusion Criteria

For the donor and the donor kidney:
- Maastricht category III DCD donors (donors who died after circulatory arrest in a controlled setting)
- Aged 50 years or older;For the recipient:
- At least 18 years of age
- Listed for renal trasplantation due to end stage renal disease on the ET or NHSBT renal waiting list within one of the participating centres
- Willingness to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations

Exclusion Criteria

For the donor and the donor kidney:
- Kidney deemed untransplantable by the retrieval surgeon. The contralateral kidney will also not be randomised as the trial is designed as a paired trial;For the recipient:
- Scheduled to undergo multi-organ transplantation
- Planned dual kidney transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Estimated Glomerular filtration rate at 1 year after transplantation (time<br /><br>window of 30 days) as determined by the EPI-CKD equation.</p><br>