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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Collaborator:
INC Research
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00609544
First received: December 10, 2007
Last updated: April 17, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Anemia
 Drug: Rilonacept
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Rilonacept
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609544

  Show 27 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
INC Research
Investigators
Study Director: Gary Swergold, MD, PhD Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Gary Swergold MD, PhD / Medical Director, Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00609544     History of Changes
Other Study ID Numbers: IL1T-AN-0704
Study First Received: December 10, 2007
Last Updated: April 17, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013