Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

August 28, 2018 updated by: Michael Kaabak, Russian Academy of Medical Sciences

Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.

Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119992
        • Russian Scientfic Center of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age 1-80
  2. weight - >6 kg
  3. male or female
  4. recipient of first kidney graft either from standard criteria deceased or live donor
  5. end stage renal disease or congenital nephrotic syndrome -

Exclusion Criteria:

  1. Blood group (ABO) incompatible transplantation
  2. presence of donor-specific anti-human leukocyte antigen (HLA) antibodies
  3. multiorgan transplantation
  4. previous transplant
  5. patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
  6. patients with haemolytic-uraemic syndrome (HUS) -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
Drug: eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
Other Names:
  • Soliris
No Intervention: control
No intervention will be applied instead eculizumab infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speed of the graft warming
Time Frame: at the time of engraftment
The speed of the graft surface warming in the range 15-20°C is accessed on the the infrared video record, taken during graft reperfusion by Nec Thermo Tracer.
at the time of engraftment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
graft morphology changes
Time Frame: one year after transplantation
Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups.
one year after transplantation
One-year graft and patient survival, as well as rejection and infection rates will be calculated
Time Frame: one year after Tx
one year after Tx
primary graft function
Time Frame: first week after Tx

initial graft function will be accessed daily during the first week post Tx and measured as follows:

  • the rate of serum creatinine decrease expressed as percent per day, where 100% will be the creatinine on the day before;
  • intragraft blood flow by Doppler indexes (acceleration, resistance) and blood flow velocity on the three levels - main, interlobar and arcuate arteries;
first week after Tx

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Russian Academy of Medical Sciences

Investigators

  • Principal Investigator: Michael M Kaabak, MD, Russian Scientific Center of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

April 15, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 27, 2012

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eculizumab for reperfusion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data, except for personal data like Name, Forename, and address, will be shared by request

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End-Stage Renal Disease

Clinical Trials on eculizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe