Skip to content

Prolonged ex-vivo normothermic machine perfusion for kidney regeneration

Prolonged ex-vivo normothermic machine perfusion for kidney regeneration

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26491
Enrollment
18
Registered
2020-03-09
Start date
2021-12-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with end-stage renal disease undergoing a kidney transplantation

Interventions

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).

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • Patients undergoing 3rd or subsequent kidney transplant • Patients undergoing a kidney transplantation from DCD Maastricht I, II & IV • Transplant recipients aged 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

Design outcomes

Primary

MeasureTime frame
The primary clinical outcome will be the glomerular filtration rate (GFR) at 6 months post transplantation.

Secondary

MeasureTime frame
Secondary clinical endpoints will include primary non-function, delayed graft function (DGF), patient and graft survival, 7 days and 3 month estimated glomerular filtration rate (eGFR-CKD EPI formula), adverse events and organ discards. Biopsies, samples of perfusate, blood and urine will be collected for biomarker analysis.

Contacts

Public ContactAsel Arykbaeva

Leiden University Medical Center

a.s.arykbaeva@lumc.nl0657316416

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)