ormothermic oxygenated kidney perfusion in elderly donors

Completed

• Conditions: chronic kidney failure; renal failure; 10038430

• Registration Number: NL-OMON44614
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Recipient age * 65 yr
- Listed for renal transplantation due to end stage renal disease on the ET list

Exclusion Criteria

- Donor kidney which is unsuitable for transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be the logistic challenges in including<br /><br>patients and treatment with normothermic ex vivo kidney perfusion (e.g. failed<br /><br>perfusion procedures, renal artery or vein thrombosis, participation rate).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Renal histology at start and end of normothermic perfusion<br /><br>2. Measured glomerular filtration rate * the best surrogate of graft function *<br /><br>(first 4 weeks, 3-months post-transplant), which is considered to be a<br /><br>predictor of long term kidney graft survival as well.<br /><br>3. 3-month graft (censored and uncensored for recipient death) and patient<br /><br>survival<br /><br>4. Incidence and severity of delayed graft function defined as the need for<br /><br>dialysis within the first 7 days after kidney transplantation and preceding the<br /><br>return of kidney function. *<br /><br>5. Incidence of primary non-function (PNF) defined as the permanent lack of<br /><br>function of the graft from time of transplantation until months<br /><br>post-transplant. This endpoint is determined post-hoc at 3 months<br /><br>post-transplant. *<br /><br>6. Biopsy proven acute rejection within 3 months post-transplant. </p><br>