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

NCT ID: NCT01731457

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-02-29

Brief Summary

The aims of this study are:

1. assessment of ischemia injury of kidney retrieved from standard and expanded criteria deceased donor before transplantation

2. assessment of efficacy of kidney ischemia injury decreasing

3. 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.

Conditions

Transplanted Kidney Ischemia Reperfusion Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Etanercept

Group Type: EXPERIMENTAL

etanercept

Intervention Type: DRUG

adding appropriate dose of etanercept to the perfusion fluid

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

etanercept

adding appropriate dose of etanercept to the perfusion fluid

Intervention Type: DRUG

Eligibility Criteria

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

• recipient of kidney form living donor
• minor recipient
• no expression of informed consent
• multiple organ recipient
• recipient "EN BLOC" kidneys or two kidneys
• recipient of kidney from donor under 14 years old
• a need of atypical urinary diversion in kidney recipient
• participation in another study at least in the last 30 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Piotr Domagała

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piotr Domagala, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Department of General Surgery and Transplantation

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

Other Identifiers

N N403 589338-WUM-PD-Poland

Identifier Type: -

Identifier Source: org_study_id