Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

This study is currently recruiting participants.

Verified March 2013 by Alexion Pharmaceuticals

Sponsor:

Information provided by (Responsible Party):

Alexion Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01399593

First received: July 19, 2011

Last updated: March 8, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2011

Last Updated Date

March 8, 2013

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary composite endpoint is the Week 9 post-transplantation treatment failure rate defined as the occurrence of 1) biopsy-proven AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up. The diagnosis of AMR will be based on kidney allograft [ Time Frame: 12 months ] [ Designated as safety issue: No ]

The primary analysis of all endpoints will occur after all patients have reached Month 12 post-transplantation.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01399593 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Official Title ^ICMJE

A Randomized, Open-label, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Living Donor Kidney Transplant Recipients Requiring Desensitization Therapy

Brief Summary

The purpose of this trial is to determine the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Antibody Mediated Rejection

Intervention ^ICMJE

Drug: Eculizumab

IV administered over 35-45 minutes

Study Arm (s)

Experimental: Eculizumab
IV administration over 35-45 minutes

Intervention: Drug: Eculizumab
No Intervention: Standard of Care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2016

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female patients ≥18 years old
Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation
Able to understand the informed consent form and willing to comply with study procedures

Exclusion Criteria:

Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mary Garfield

203-271-6481

Transplant@alxn.com

Location Countries ^ICMJE

United States, Australia, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01399593

Other Study ID Numbers ^ICMJE

C10-001, 2010-019630-28, BB-IND: 100,003

Has Data Monitoring Committee

Yes

Responsible Party

Alexion Pharmaceuticals

Study Sponsor ^ICMJE

Alexion Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Alexion Pharmaceuticals

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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