*In house* Pre-implantation Oxygenated Hypothermic Machine Perfusion Reconditioning after Cold Storage versus Cold Storage alone in ECD Kidneys from Brain Dead Donors

Phase 3

Completed

• Conditions: End stage kidney failure/End stage renal disease; 10029149; 10038365

• Registration Number: NL-OMON41997
• Lead Sponsor: Oxford University

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: 40

Inclusion Criteria

For the donor and the donated kidney:
- All kidneys from DBD donors (Donation after BrainDeath) fulfilling the UNOS-ECD criteria; donors aged 60 years or older, or donors aged 50 years or older with two of the following riskfactors: hypertension. terminal creatinin >1,5mg/dL or a cerebral vascular cause of death.;For the recipient of the donated kidney:
- Aged 18 years or older
- Listed for renal transplantation due to end stage renal disease on the ET or NHSBT renal waiting list within one of the participating centers.
- Participant is willing to participate in the study and has provided written informed consent.
- This transplantation is the participant's first or re-transplantation.

Exclusion Criteria

For the donor and the donated kidney:
- Kidneys used for a multi-organ transplant procedure.
- Kidneys from standard criteria donors (SCD).
- Kidneys procured from a DCD donor (Donation after Circulatory Death).
- Kidneys used for a double kidney transplant within the same recipient.
- Kidneys procured from donors older than 85 years.;For the recipient:
- Simultaneous participation in another perfusion trial.
- Scheduled to undergo multi-organ transplantation.
- Planned dual-kidney transplantation.
- Is unable or unwilling to provide informed consent.
- If the kidney is judged to be not transplantable.
- Simultaneous participation in another perfusion trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome for this study is Graft survival at 12 months after<br /><br>transplantation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Patient and (death censored) graft survival at day 7, 3, 6 and 12 months<br /><br>after transplantation. eGFR defined by the MDRD equation at day 7, 3, 6 and 12<br /><br>months after transplantation.<br /><br>- Delayed graft function defined as the need for dialysis in the first 7 days<br /><br>after transplantation and preceding the return of kidney function.<br /><br>- Slow graft function based on functional DGF defined as the absence of<br /><br>decrease in the serum creatinine level of at least 10% per day for at least 3<br /><br>consecutive days in the first 7 days after transplantation.<br /><br>- Primary non-function defined as the continued need for dialysis at 3 months<br /><br>after transplantation.<br /><br>- Comparison of biopsy proven acute rejection between the 2 groups.<br /><br>- Quality of life measures (EQ-5D-5L) at consent, 3 and 12 months, length of<br /><br>hospital stay (including ICU) and need/length for dialysis treatment</p><br>