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

This study is currently recruiting participants.
Verified November 2012 by Medical University of Warsaw
Sponsor:
Information provided by (Responsible Party):
Piotr Domagała, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01731457
First received: November 15, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Transplanted Kidney Ischemia Reperfusion Injury
 Drug: etanercept
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
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)
Arms Assigned Interventions
Experimental: Etanercept Drug: etanercept
adding appropriate dose of etanercept to the perfusion fluid
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731457

Contacts
Contact: Piotr Domagala, MD, PhD +48501733062 pdomagal@mp.pl
Contact: Artur Kwiatkowski, MD, PhD, Prof +48225021915 kwiateka@o2.pl

Locations
Poland
Department of General Surgery and Transplantation Recruiting
Warsaw, Mazowieckie, Poland, 02-006
Contact: Piotr Domagala, MD, PhD     +48501733062        
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Piotr Domagala, MD, PhD Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Piotr Domagała, MD, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01731457     History of Changes
Other Study ID Numbers: N N403 589338-WUM-PD-Poland
Study First Received: November 15, 2012
Last Updated: November 28, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
ischemia, reperfusion, kidney, transplantation

Additional relevant MeSH terms:
Hypothermia
Ischemia
Reperfusion Injury
Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013