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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

This study has been withdrawn prior to enrollment.
(Unable to enroll patients)
INC Research
Information provided by:
Regeneron Pharmaceuticals Identifier:
First received: December 10, 2007
Last updated: April 17, 2011
Last verified: April 2011

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.

Condition Intervention Phase
Chronic Kidney Disease
Drug: Rilonacept
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change in blood hemoglobin concentration. [ Time Frame: Baseline to Week 12 ]

Enrollment: 0
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00609544

  Hide Study Locations
United States, Alabama
Alexander City, Alabama, United States
Muscle Shoals, Alabama, United States
United States, California
Cerritos, California, United States
Long Beach, California, United States
Los Alampios, California, United States
Thousand Palms, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Florida
Lauderdale Lakes, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
United States, Georgia
Blue Ridge, Georgia, United States
Jonesboro, Georgia, United States
United States, Maine
Portland, Maine, United States
United States, New York
Queens, New York, United States
United States, North Carolina
Mooresville, North Carolina, United States
Shelby, North Carolina, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
United States, South Carolina
Orangeburg, South Carolina, United States
Sumter, South Carolina, United States
United States, Tennessee
Barlett, Tennessee, United States
Clarksville, Tennessee, United States
Collierville, Tennessee, United States
Crossville, Tennessee, United States
Memphis, Tennessee, United States
United States, Utah
Ogden, Utah, United States
United States, Virginia
Falls Church, Virginia, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
INC Research
Study Director: Gary Swergold, MD, PhD Regeneron Pharmaceuticals
  More Information

Responsible Party: Gary Swergold MD, PhD / Medical Director, Regeneron Pharmaceuticals Identifier: NCT00609544     History of Changes
Other Study ID Numbers: IL1T-AN-0704
Study First Received: December 10, 2007
Last Updated: April 17, 2011

Keywords provided by Regeneron Pharmaceuticals:
Non Dialysis-dependent chronic kidney disease and anemia

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Hematologic Diseases processed this record on May 25, 2017