Overview

This trial is active, not recruiting.

Condition stage v chronic kidney disease
Treatment eculizumab
Phase phase 2
Target C5
Sponsor Alexion Pharmaceuticals
Start date May 2012
End date June 2015
Trial size 80 participants
Trial identifier NCT01567085, 2010-019631-35, C10-002

Summary

Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent Antibody Mediated Rejection (AMR) in sensitized recipients of deceased donor kidney transplants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
eculizumab
Eculizumab 1200 mg (4 vials) administered intravenously (IV) over 35 to 45 minutes. Eculizumab 900 mg (3 vials) administered IV over 35 to 45 minutes.

Primary Outcomes

Measure
Post-transplantation treatment failure rate
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Male or female patients ≥ 18 years old 2. Patients with Stage V chronic kidney disease who will receive a kidney transplant from a deceased donor to whom they are sensitized 3. History of prior exposure to HLA (Human Leukocyte Antigen): - Prior solid organ or tissue allograft - Pregnancy - Blood transfusion - Prior exposure to specific donor's HLA Exclusion Criteria: 1. Has received treatment with eculizumab at any time prior to enrolling in this study 2. ABO (A,B and O Blood Glycoproteins-Blood Type) incompatible with deceased donor 3. History of severe cardiac disease 4. Prior splenectomy

Additional Information

Official title An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Alexion Pharmaceuticals.