Comparing kidney perfusion methods for transplants
A Single-center, Pilot, Prospective, Randomized Clinical Study of Hypothermic Oxygenated Perfusion With or Without Adsorption in Histologically Evaluated Kidneys Retrieved From Marginal Donors
This study is testing if using a special system to clean kidneys from older or less healthy donors before transplant can help them work better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Locations | 1 site (Bergamo, BG) |
| Trial ID | NCT06374121 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of kidney perfusion with and without the use of an adsorption system in improving the function of kidneys from marginal donors prior to transplantation. It involves a randomized allocation of kidneys to either a perfusion group with the PerSorb cartridge or a control group using the Integrated PerLife® system alone. The study will assess biochemical profiles and functional parameters of the kidneys to determine the impact of the adsorption method on transplant outcomes. The focus is on kidneys from older donors or those with specific health conditions that may affect transplant viability.
Who should consider this trial
Good fit: Ideal candidates are individuals over 50 years old who are eligible for kidney transplantation from marginal donors.
Not a fit: Patients who do not meet the criteria for marginal donors or have contraindications for kidney transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance kidney transplant outcomes and reduce complications for patients receiving organs from marginal donors.
How similar studies have performed: Previous studies have shown promising results with machine perfusion techniques in organ transplantation, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females older than 50 years eligible for single or dual kidney transplant from marginal donors identified according to the NITp criteria (\>70-year-old or 60 to 70 years with hypertension and/or diabetes and/or clinical proteinuria) * Pre-transplant histological evaluation * Histological score ≤ 7 * Written informed consent. Exclusion Criteria: * Any factor that represents a contraindication to receive a deceased donor kidney transplant according to the NITp criteria, * Need for specific desensitization protocols because of a high immunological risk according to the NITp criteria, * Active enrollment in concomitant intervention studies, * Macroscopic vascular abnormalities that preclude the possibility of machine perfusion.
Where this trial is running
Bergamo, BG
- ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/ Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò — Bergamo, Bg, Italy (Recruiting)
Study contacts
- Study coordinator: Camillo Carrara, MD
- Email: pruggenenti@asst-pg23.it
- Phone: +3903545351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.