Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function
Recruitment status was: Recruiting
The aims of this study are:
- assessment of ischemia injury of kidney retrieved from standard and expanded criteria deceased donor before transplantation
- assessment of efficacy of kidney ischemia injury decreasing
- assessment of influence of kidney ischemia injury decreasing on its function after transplantation For the purpose of this research one hundred kidney will be retrieved from deceased donors (standard and expanded criteria deceased donors) for transplantation. All kidneys before transplantation will be stored in machine perfusion in hypothermia with continuous flow - Organ Recovery Systems LifePort - each single kidney in self-contained perfusion system.
For the kidney allograft assessment will be used measurements performed during machine perfusion in hypothermia: renal flow, resistance, lactate dehydrogenase, lactates and ischemia injury markers measured in the fourth hour of perfusion in perfusion fluid.
For kidney ischemia injury assessment such markers will be measured: tumour necrosis factor (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1), neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3.
Every time from pair of retrieved kidneys each kidney will be randomise for one of the group:
- group 1) - 50 kidneys - examined group - "cured" with etanercept (ENBREL) in the first hour of perfusion by adding drug to perfusion fluid,
- group 2) - 50 kidneys - control group - without intervention. Ischemia injury markers will be measured in perfusion fluid by kidney two times (in the first and fourth hour of perfusion) for assessment of efficacy kidney ischemia injury decreasing.
Results of measurements of kidney ischemia injury before transplantation, parameters during machine perfusion in hypothermia and donor parameters will be correlated with kidney allograft function post transplantation.
Immediate, delayed and slow graft function, primary non-function, kidney function assessed by creatinine concentration and creatinine clearance at one day, seven days, two weeks, 1, 6 and 12 months post transplantation and kidney graft survival 6 and 12 months post transplantation will be analysed.
Transplanted Kidney Ischemia Reperfusion Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function|
- delayed graft function [ Time Frame: one week ] [ Designated as safety issue: No ]a need at least one dialysis during first week after transplantation
- 6 months graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]survival of kidney grafts 6 months after transplantation
- 12 months graft survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]survival of kidney grafts 12 months after transplantation
- acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]biopsy proven acute rejection episodes during the first year after transplantation
- kidney ischemia injury assessment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]ischemia injury markers measured two times (in the first and fourth hour of perfusion) in perfusion fluid: tumour necrosis factor (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1), neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
adding appropriate dose of etanercept to the perfusion fluid
|No Intervention: Control|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731457
|Department of General Surgery and Transplantation|
|Warsaw, Mazowieckie, Poland, 02-006|
|Principal Investigator:||Piotr Domagala, MD, PhD||Medical University of Warsaw|