Kidney Perfusion With or Without Absorption

NCT06374121 · tracked via the Priya Life Science Italy tracker

Sponsor

Mario Negri Institute for Pharmacological Research

Phase

Not applicable

Started

2024-10-22

Last updated

2024-11-22

Condition(s) studied

Kidney Replacement

Investigational drug(s) / intervention(s)

PerSorb cartridge (CytoSorbents Europe GmbH, Germany)PerLife PerKidney

PerSorb 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.

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

Study 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

Sex

ALL

Min age

50 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Oxidative stress markers — Every 30 minutes during clinical perfusion
Glutathione S-transferase (GST), lactate dehydrogenase (LDH) and free lactate
Acute kidney injury markers — Every 30 minutes during clinical perfusion
Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1) and endothelin
Inflammatory cytokine markers — Every 30 minutes during clinical perfusion
Interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor alpha (TNF-⍺)
Complement activation markers — Every 30 minutes during clinical perfusion
Complement factor 3a (C3a), complement factor 5a (C5a) and soluble membrane attack complex (sC5bC9)
Vascular resistances — Every 30 minutes during clinical perfusion
Renal vascular resistances will be automatically collected through clinical perfuzione
Perfusate sample collection — At clinical perfusion start, after 1 hour, then after 4 hours from start and every 2 hours thereafter, up to perfusion end
Pseudo-urine ureteral output will be separately assessed at sequential times during clinical perfusion

Trial sites (1)

Facility	City	Region	Status
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	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06374121 on ClinicalTrials.gov ↗ ← All trials in Italy