Comparing kidney perfusion methods for transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.