Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia

April 17, 2011 updated by: Regeneron Pharmaceuticals

A Multi-Center, Double-Blind, Placebo-Controlled Safety and Preliminary Efficacy Study of IL-1 Trap (Rilonacept) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia

Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. This decreased responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept is being developed for the treatment of inflammatory disorders.

This is a clinical research study to determine the safety and effectiveness of rilonacept for the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alexander City, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • California
      • Cerritos, California, United States
      • Long Beach, California, United States
      • Los Alampios, California, United States
      • Thousand Palms, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Lauderdale Lakes, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Blue Ridge, Georgia, United States
      • Jonesboro, Georgia, United States
    • Maine
      • Portland, Maine, United States
    • New York
      • Queens, New York, United States
    • North Carolina
      • Mooresville, North Carolina, United States
      • Shelby, North Carolina, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Harrisburg, Pennsylvania, United States
    • South Carolina
      • Orangeburg, South Carolina, United States
      • Sumter, South Carolina, United States
    • Tennessee
      • Barlett, Tennessee, United States
      • Clarksville, Tennessee, United States
      • Collierville, Tennessee, United States
      • Crossville, Tennessee, United States
      • Memphis, Tennessee, United States
    • Utah
      • Ogden, Utah, United States
    • Virginia
      • Falls Church, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female greater than 18 years of age
  • Chronic Kidney Disease (CKD) not yet requiring renal replacement therapy (pre-dialysis patients)
  • Not expected to require dialysis during duration of the study
  • Adequate laboratory values
  • If on rHuEPO therapy, the dose must be stable

Exclusion Criteria:

  • Persistent chronic or active infections
  • Intravenous (IV) iron administration within 12 weeks prior to the Screening Visit
  • Known history of severe uncontrolled hyperparathyroidism
  • Prior recipient or scheduled to receive a kidney transplant during the study
  • Abnormal laboratory values
  • Unstable angina or myocardial infarction within the past 6 months prior to the Screening Visit
  • Uncontrolled hypertension
  • Coronary disease diagnosed in the 3 months prior to the Screening Visit
  • Severe Congestive Heart Failure
  • History of HIV
  • Hepatitis B and/or Hepatitis C
  • Abnormal chest radiograph
  • A positive intradermal skin tuberculin test
  • History or presence of cancer within 5 years of the Screening Visit
  • History of alcohol abuse or current intake of 21 or more alcohol-containing drinks per week
  • History of drug abuse within the 5 years prior to the Screening Visit
  • Lactating females or pregnant females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Rilonacept
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
Placebo Comparator: 2
Drug: Rilonacept
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in blood hemoglobin concentration.
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Syneos Health

Investigators

  • Study Director: Gary Swergold, MD, PhD, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 17, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL1T-AN-0704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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