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

Phase 1

Conditions: Antiobdy mediated rejection after kidney transplant
MedDRA version: 14.1Level: LLTClassification code 10064683Term: Antibody-mediated rejectionSystem Organ Class: 100000004870
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2010-019630-28-NL

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

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 89
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy prior to transplantation;Secondary Objective: Safety and Efficacy;Primary end point(s): To evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.;Timepoint(s) of evaluation of this end point: 9 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cumulative incidence of AMR that occur between week 9 and month 12 post-transplantation.;Timepoint(s) of evaluation of this end point: 1 year