Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

NCT01756508 | Completed Phase 2

• 1 other identifier: Eculizumab for reperfusion
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

eculizumab; kidney transplantation; reperfusion; rejection; infection

Outcome Measures

Primary Outcomes (1)

• 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.

  at the time of engraftment

Secondary Outcomes (3)

• graft morphology changes

  one year after transplantation

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

  one year after Tx

• primary graft function

  first week after Tx

Study Arms (2)

eculizumab

EXPERIMENTAL

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

Drug: eculizumab

control

NO INTERVENTION

No intervention will be applied instead eculizumab infusion

Interventions

eculizumab DRUG

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

Also known as: Soliris

eculizumab

Eligibility Criteria

• Age: 12 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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) -

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead

Study Sites (1)

Russian Scientfic Center of Surgery

Moscow, 119992, Russia

Location

Related Publications (2)

• 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.

  PMID: 23348894 BACKGROUND

• 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.

  PMID: 29377474 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency; Rejection, Psychology; Infections

Interventions

eculizumab

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Michael M Kaabak, MD

  Russian Scientific Center of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: September 1, 2012
• Primary Completion: April 15, 2017
• Study Completion: December 1, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)