A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant

• Status: Terminated
• Trial end date: 2014-02-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Schroppel, Bernd, M.D.
• Collaborator: Alexion Pharmaceuticals
• Treatments: Eculizumab

Criteria

Inclusion Criteria:

• Age 18 or older

• Weight > 40 kg

• Male or Female

• Recipients of first deceased donor kidneys

• Able to provide written informed consent

• Transplant candidate as per site specific guidelines

• Dialysis dependent renal failure (initiated more than 2 months prior to transplant)

• Novartis Delayed Graft Function Score 3-8

• Extended criteria donor with brain death, or standard criteria donor with cold ischemic time < 24 hours

Exclusion Criteria:

• Planned to receive multi-organ transplant

• Kidneys from donors < 6 years of age

• Dual kidney transplant (from same donor, including en bloc)

• Living donor kidney

• Highly sensitized recipients (PRA > 50%)

• Previous transplant

• Participation in another investigational trial

• Recipient BMI > 40

• ABO incompatible

• DCD Donor

• Preemptive kidney transplant

• Recipients with DGF scores < 3 or > 8

• Women who are pregnant or breast feeding

• Women of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception

• Patients infected with HIV, HCV or HBV

• Active bacterial or other infection which is clinically significant in the opinion of the investigator

• Patients with history of splenectomy

• Patients with history of meningococcal disease

• Patients with known or suspected hereditary complement deficiency

• Patients with history of cancer (other than non-melanoma skin cancers) within the last 5 years