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

NCT ID: NCT01403389

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-01
• Study Completion Date: 2014-02-06

Brief 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.

Detailed 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.

Conditions

Delayed Function of Renal Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Eculizumab

Group Type: EXPERIMENTAL

Eculizumab

Intervention Type: DRUG

1200 milligrams Eculizumab diluted in 0.9% NaCl to 5mg/mL for a total volume of 240 mL administered by IV infusion over 35 minutes in the operating room prior to organ reperfusion

0.9% Sodium Chloride

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion

Interventions

Eculizumab

1200 milligrams Eculizumab diluted in 0.9% NaCl to 5mg/mL for a total volume of 240 mL administered by IV infusion over 35 minutes in the operating room prior to organ reperfusion

Intervention Type: DRUG

Placebo

240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion

Intervention Type: DRUG

Other Intervention Names

Soliris; 0.9% Sodium Chloride

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Schroppel, Bernd, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernd Schroppel, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Recanati/Miller Transplantation Institute

New York, New York, United States

Countries

United States

Other Identifiers

HSM 10-1600

Identifier Type: -

Identifier Source: org_study_id