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

NCT01731457 | Completed Phase 2

• 1 other identifier: N N403 589338-WUM-PD-Poland
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are:

• 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

Keywords

ischemia, reperfusion, kidney, transplantation

Outcome Measures

Primary Outcomes (2)

• delayed graft function

  a need at least one dialysis during first week after transplantation

  one week

• 12 months graft survival

  survival of kidney grafts 12 months after transplantation

  12 months

Secondary Outcomes (2)

• acute rejection

  12 months

• kidney ischemia injury assessment

  4 hours

Study Arms (2)

Etanercept

EXPERIMENTAL

Drug: etanercept

Control

NO INTERVENTION

Interventions

etanercept DRUG

adding appropriate dose of etanercept to the perfusion fluid

Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of General Surgery and Transplantation

Warsaw, Masovian Voivodeship, 02-006, Poland

Location

MeSH Terms

Conditions

Ischemia

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Piotr Domagala, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2016
• Last Updated: May 10, 2017

Record last verified: 2016-12

Locations

PL (1)