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

NCT01403389 | Terminated Phase 2 DMC

• 1 other identifier: HSM 10-1600
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Delayed Function of Renal Transplant

Keywords

Kidney Transplant; Delayed Graft Function

Outcome Measures

Primary Outcomes (1)

• Composite of Delayed Graft Function and Slow Graft Function

  Delayed Graft Function defined as follows: 1. A need for at least one dialysis treatment during the first 7 days after transplantation (not including a single session for hyperkalemia or hypervolemia in the first 48 hours) 2. A less than or equal to 50% reduction in serum creatinine in the first 24 hours post-transplantation 3. A serum creatinine reduction ratio \< 30% at 48 hours post-transplantation Slow Graft Function Defined as Follows: A functioning graft at Day 5 Post-transplantation with a serum creatinine \> 3 mg/dL and no need for dialysis

  Up to 6 months

Study Arms (2)

Eculizumab

EXPERIMENTAL

Drug: Eculizumab

0.9% Sodium Chloride

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Eculizumab 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

Also known as: Soliris

Eculizumab

Placebo DRUG

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

Also known as: 0.9% Sodium Chloride

0.9% Sodium Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Schroppel, Bernd, M.D.: lead
• Alexion Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Mount Sinai Recanati/Miller Transplantation Institute

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Delayed Graft Function

Interventions

eculizumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bernd Schroppel, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: December 1, 2011
• Primary Completion: August 6, 2013
• Study Completion: February 6, 2014
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

US (1)