Kidney Perfusion With or Without Absorption
ConditionKidney Replacement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMario Negri Institute for Pharmacological Research
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PerSorb cartridge (CytoSorbents Europe GmbH, Germany)
DeviceThis is a highly bio-/hemo-compatible, low-flow resistance polymer cartridge able to remove cytokines and other inflammatory mediators via adsorption.
PerLife PerKidney
DeviceThe system for ex vivo kidney reconditioning (Aferetica, Italy), which allows hypothermic oxygenated pulsatile perfusion of the organ.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Perfusion and concomitant adsorptionExperimental treatment 2 interventions
Group B: Perfusion aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oxidative stress markers
Glutathione S-transferase (GST), lactate dehydrogenase (LDH) and free lactate
Time frame
Every 30 minutes during clinical perfusion2
Acute kidney injury markers
Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1) and endothelin
Time frame
Every 30 minutes during clinical perfusion3
Inflammatory cytokine markers
Interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor alpha (TNF-⍺)
Time frame
Every 30 minutes during clinical perfusion4
Complement activation markers
Complement factor 3a (C3a), complement factor 5a (C5a) and soluble membrane attack complex (sC5bC9)
Time frame
Every 30 minutes during clinical perfusionSponsors and contacts
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Source ClinicalTrials.gov