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Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Primary Purpose

End-Stage Renal Disease, Kidney Failure, Graft Reperfusion Injury

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

eculizumab

About this trial

This is an interventional prevention trial for End-Stage Renal Disease focused on measuring eculizumab, kidney transplantation, reperfusion, rejection, infection

Eligibility Criteria

12 Months - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Russian Scientfic Center of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eculizumab

control

Arm Description

Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion

No intervention will be applied instead eculizumab infusion

Outcomes

Primary Outcome Measures

speed of the graft warming

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.

Secondary Outcome Measures

graft morphology changes

Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups.

One-year graft and patient survival, as well as rejection and infection rates will be calculated

primary graft function

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;

Full Information

NCT ID

NCT01756508

First Posted

December 20, 2012

Last Updated

August 28, 2018

Sponsor

Russian Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01756508

Brief Title

Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2012 (Actual)

Primary Completion Date

April 15, 2017 (Actual)

Study Completion Date

December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Russian Academy of Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-Stage Renal Disease, Kidney Failure, Graft Reperfusion Injury

Keywords

eculizumab, kidney transplantation, reperfusion, rejection, infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

eculizumab

Arm Type

Experimental

Arm Description

Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion

Arm Title

control

Arm Type

No Intervention

Arm Description

No intervention will be applied instead eculizumab infusion

Intervention Type

Drug

Intervention Name(s)

eculizumab

Other Intervention Name(s)

Soliris

Intervention Description

Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion

Primary Outcome Measure Information:

Title

speed of the graft warming

Description

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.

Time Frame

at the time of engraftment

Secondary Outcome Measure Information:

Title

graft morphology changes

Description

Protocol biopsy will be obtained at one month and one year. Progression of allograft nephropathy will be compared between groups.

Time Frame

one year after transplantation

Title

One-year graft and patient survival, as well as rejection and infection rates will be calculated

Time Frame

one year after Tx

Title

primary graft function

Description

Time Frame

first week after Tx

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 1-80 weight - >6 kg male or female recipient of first kidney graft either from standard criteria deceased or live donor end stage renal disease or congenital nephrotic syndrome - Exclusion Criteria: Blood group (ABO) incompatible transplantation presence of donor-specific anti-human leukocyte antigen (HLA) antibodies multiorgan transplantation previous transplant patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV) patients with haemolytic-uraemic syndrome (HUS) -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael M Kaabak, MD

Organizational Affiliation

Russian Scientific Center of Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Russian Scientfic Center of Surgery

City

Moscow

ZIP/Postal Code

119992

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

23348894

Citation

de Vries DK, van der Pol P, van Anken GE, van Gijlswijk DJ, Damman J, Lindeman JH, Reinders ME, Schaapherder AF, Kooten Cv. Acute but transient release of terminal complement complex after reperfusion in clinical kidney transplantation. Transplantation. 2013 Mar 27;95(6):816-20. doi: 10.1097/TP.0b013e31827e31c9.

Results Reference

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PubMed Identifier

29377474

Citation

Kaabak M, Babenko N, Shapiro R, Zokoyev A, Dymova O, Kim E. A prospective randomized, controlled trial of eculizumab to prevent ischemia-reperfusion injury in pediatric kidney transplantation. Pediatr Transplant. 2018 Mar;22(2). doi: 10.1111/petr.13129. Epub 2018 Jan 29.

Results Reference

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Learn more about this trial

Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

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