OPEN LABEL TRIAL OF ECULIZUMAB IN THE PREVENTION OF AMR IN DECEASED DONOR KIDNEY TRANSPLANT SENSITIZED RECIPIENTS

Phase 1

• Conditions: Antibody mediated rejection after kidney transplant; MedDRA version: 14.1Level: LLTClassification code 10064683Term: Antibody-mediated rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2010-019631-35-ES
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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. Patients must be able to understand the informed consent form and willing to comply with study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Has received treatment with eculizumab at any time prior to enrolling in this study
2. ABO incompatible with deceased donor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified