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 - Full Text View

Sponsors and Collaborators:	Regeneron Pharmaceuticals Kendle International
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00609544

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 II

MedlinePlus related topics: Anemia

Drug Information available for: Rilonacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
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

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Change in blood hemoglobin concentration. [ Time Frame: Baseline to Week 12 ]

Enrollment:	0
Study Start Date:	November 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Rilonacept Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
2: Placebo Comparator	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

Kendle International

Investigators

Study Director:

Gary Swergold, MD, PhD

Regeneron Pharmaceuticals

More Information

Responsible Party:	Regeneron Pharmaceuticals ( Gary Swergold MD, PhD / Medical Director )
Study ID Numbers:	IL1T-AN-0704
Study First Received:	December 10, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00609544
Health Authority:	United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:

Non Dialysis-dependent chronic kidney disease and anemia

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009