Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function

Medical University of Warsaw

Status and phase

Completed

Phase 2

Conditions

Transplanted Kidney Ischemia Reperfusion Injury

Treatments

Drug: etanercept

Study type

Interventional

Funder types

Other

Identifiers

NCT01731457

N N403 589338-WUM-PD-Poland

Details and patient eligibility

About

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.

Enrollment

94 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

DONOR STAGE

donor after brain death
seronegative HCV (hepatitis C virus)
procurement of two kidneys from the same donor
donor center distance up to 220 kilometres from Warsaw
availability of fluid KPS-1 and cartridge of Organ Recovery System

RECIPIENT STAGE

recipient of kidneys from deceased donor
at least eighteen recipient
expression of informed consent

Exclusion criteria

DONOR STAGE

live kidney donor
seropositive HCV (hepatitis C virus)
get only one from the kidneys
"doubtful" donor - e.g. need for biopsy because of proteinuria or due to histological lesions (e.g. tumor)
donor center distance above 220 kilometres from Warsaw
lack of fluid KPS-1 and cartridge of Organ Recovery System

RECIPIENT STAGE