Skip to main content
OpenTrials
Completed

NCT Number: NCT01731457

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transplanted Kidney Ischemia Reperfusion Injury Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of General Surgery and Transplantation

Warsaw, Masovian Voivodeship, 02-006, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

adding appropriate dose of etanercept to the perfusion fluid

Primary outcomes

  1. delayed graft function

    Time frame: one week

    a need at least one dialysis during first week after transplantation

  2. 12 months graft survival

    Time frame: 12 months

    survival of kidney grafts 12 months after transplantation

Secondary outcomes

  1. acute rejection

    Time frame: 12 months

    biopsy proven acute rejection episodes during the first year after transplantation

  2. kidney ischemia injury assessment

    Time frame: 4 hours

    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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Nov 21, 2012
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.