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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This study has been withdrawn prior to enrollment.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

December 10, 2007
April 17, 2011
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Change in blood hemoglobin concentration. [ Time Frame: Baseline to Week 12 ]
Same as current
Complete list of historical versions of study NCT00609544 on ClinicalTrials.gov Archive Site
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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
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Anemia
Drug: Rilonacept
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
  • Experimental: 1
    Intervention: Drug: Rilonacept
  • Placebo Comparator: 2
    Intervention: Drug: Rilonacept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00609544
IL1T-AN-0704
No
Gary Swergold MD, PhD / Medical Director, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
INC Research
Study Director: Gary Swergold, MD, PhD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP