Study of Eculizumab in Adult Subjects at Risk for Developing Delayed Graft Function.

Phase 1

• Conditions: Delayed Graft Function; MedDRA version: 17.0Level: LLTClassification code 10048747Term: Renal graft function delayedSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-004650-25-FR
• Lead Sponsor: Alexion Pharmaceuticals Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-31
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

- male or female, 18 years or older
- Subject with dialysis dependent renal failure (initiated more than 2 months prior to transplant).
- Subject is to receive a first kidney transplant from a deceased donor at risk of DGF
- Subject able to provide written informed consent
- Female subjects of child-bearing potential must have a negative serum pregnancy test (serum beta-hCG) and an approved contraceptive regimen
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 258
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

- Subject to receive multi-organ transplant
- Subject to receive kidney(s) from donors < 6 years of age
- Subject to receive a dual kidney transplant (from same donor, including en bloc)
- Subject to receive a living donor kidney
- Subject is highly sensitized to the donor
- Subject has received any previous transplant

Study & Design

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