Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756508
• Other study ID #: Eculizumab for reperfusion
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2012
• Est. completion date: December 1, 2017

Study information

• Verified date: August 2018
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 1, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 80 Years

Eligibility

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) -

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Graft Reperfusion Injury
• Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Reperfusion Injury
• Wounds and Injuries

Intervention

Drug:
• eculizumab
Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion

Locations

Country	Name	City	State
Russian Federation	Russian Scientfic Center of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 after transplantation
Secondary	One-year graft and patient survival, as well as rejection and infection rates will be calculated		one year after Tx
Secondary	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;	first week after Tx