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Kidney Perfusion With or Without Absorption

RecruitingNAAges 50 Years - anyAllMario Negri Institute for Pharmacological Research
NCT06374121 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ki

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📋 Eligibility rules (as published)
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.
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What it tests

  • PerSorb cartridge (CytoSorbents Europe GmbH, Germany)
  • PerLife PerKidney
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Where

1 site
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, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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