RecruitingNot ApplicableNCT06374121

Kidney Perfusion With or Without Absorption

A Single-center, Pilot, Prospective, Randomized Clinical Study of Hypothermic Oxygenated Perfusion With or Without Adsorption in Histologically Evaluated Kidneys Retrieved From Marginal Donors


Sponsor

Mario Negri Institute for Pharmacological Research

Enrollment

10 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this single-center, pilot, prospective, randomized study, the investigators will compare the biochemical profiles of the perfusate and the functional parameters of five kidneys perfused with Integrated PerLife® system and "PerSorb ECOS-300CY ™" sorbent (adsorption groups) with the profiles of the perfusate and functional parameters of five matched kidneys perfused with Integrated PerLife® system only (non-adsorption group). Kidneys from marginal donors with a clinical indication to pre-transplant histological evaluation (donor \>70-years-old or aged 60 to 69 years but with hypertension, diabetes and/or clinical proteinuria) will be allocated to perfusion with or without adsorption using a 1:1 randomization ratio. When both donor kidneys will have a score from 0 to 4, the two kidneys will be used for two single transplants. When one kidney will have a score from 0 to 4 and the other kidney will have a score of 5 or more, and when both kidneys will have a score from 5 to 7, the two kidneys will be transplanted together into the same recipient. If one kidney will have a score from 5 to 7 and the other kidney will have a score of 8 or greater, the two kidneys will be discarded. With the use of the minimization method, the randomization will be planned in order to have the same number of single or dual transplants in the perfusion kidney groups with or without adsorption. Donor selection, kidney evaluation and allocation and recipient management will be based on per center practice.


Eligibility

Min Age: 50 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

DEVICEPerSorb cartridge (CytoSorbents Europe GmbH, Germany)

This is a highly bio-/hemo-compatible, low-flow resistance polymer cartridge able to remove cytokines and other inflammatory mediators via adsorption.

DEVICEPerLife PerKidney

The system for ex vivo kidney reconditioning (Aferetica, Italy), which allows hypothermic oxygenated pulsatile perfusion of the organ.


Locations(1)

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

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NCT06374121


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