Actively Recruiting
Kidney Perfusion With or Without Absorption
Led by Mario Negri Institute for Pharmacological Research · Updated on 2024-11-22
10
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Kidney Perfusion With or Without Absorption
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 7
- Written informed consent.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
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, 24027
Actively Recruiting
Research Team
C
Camillo Carrara, MD
CONTACT
P
Piero L Ruggenenti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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