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Clinical Trials/EUCTR2010-019631-35-IT
EUCTR2010-019631-35-ITActive, not recruitingPhase 1

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

ALEXION PHARMACEUTICALS0 sites40 target enrollmentStarted: June 8, 2012Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Male or female patients =18 years old 2. Patients with Stave V chronic kidney disease who will recieve a kindney 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: 0
  • •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

Investigators

Similar Trials

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OPEN LABEL TRIAL OF ECULIZUMAB IN THE PREVENTION OF AMR IN DECEASED DONOR KIDNEY TRANSPLANT SENSITIZED RECIPIENTSAntibody mediated rejection after kidney transplantMedDRA version: 14.1Level: LLTClassification code 10064683Term: Antibody-mediated rejectionSystem Organ Class: 10021428 - Immune system disorders
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OPEN LABEL CONTROLLED TRIAL OF ECULIZUMAB IN THE PREVENTION OF AMR IN LIVING DONOR KIDNEY TRANSPLANT RECIPIENTS REQUIRING DESENSITIZATIO
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