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

Schroppel, Bernd, M.D.

Status and phase

Terminated

Phase 2

Conditions

Delayed Function of Renal Transplant

Treatments

Drug: Eculizumab

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01403389

HSM 10-1600

Details and patient eligibility

About

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.

Full description

Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that eculizumab, an antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. To test this hypothesis, this study is a pilot prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation in preventing delayed graft function in first adult recipients of deceased donor kidneys.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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