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

Phase 1

Conditions: Delayed Graft Function
MedDRA version: 17.1Level: LLTClassification code 10048747Term: Renal graft function delayedSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-004650-25-DE

Lead Sponsor: Alexion Pharmaceuticals Incorporated

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy and safety of eculizumab to prevent DGF in adult diseased donor kidney transplants recipients at increased risk of DGF.;Secondary Objective: - Safety and tolerability of eculizumab.<br>- Efficacy (graft function, subject and graft survival, biopsy proven acute rejection).;Primary end point(s): Incidence of DGF;Timepoint(s) of evaluation of this end point: First week post transplantation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Graft function<br>- need for dialysis<br>- Estimated Glomerular Filtration Rate (eGFR)<br>- Rejection-free graft survival;Timepoint(s) of evaluation of this end point: -Graft function : first 7 days post transplantation<br>-Need for dialysis : first 30 post transplantation<br>-Estimated Glomerular Filtration Rate : days 7, 14, 28, 60, 90, weeks 26 and week 52 post transplantation<br>-Rejection-free graft survival : week 26 and week 52 post transplantation