OPEN LABEL CONTROLLED TRIAL OF ECULIZUMAB IN THE PREVENTION OF AMR IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATIO

• Conditions: Antiobdy 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: EUCTR2010-019630-28-ES
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-30
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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
- Patients must be willing and able to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Has received treatment with eculizumab at any time prior to enrolling in this study
- ABO incompatible with living donor

Study & Design

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