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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Delayed Function of Renal Transplant

In brief

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.

Key facts

Study ID

NCT01403389

Run by

Schroppel, Bernd, M.D.

People needed

8

Starts

2011-12-01

Expected to finish

2014-02-06

Last updated by the study team

2019-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai Recanati/Miller Transplantation Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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