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This study has been withdrawn prior to enrollment.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

Tracking Information

First Received Date ^ICMJE

December 10, 2007

Last Updated Date

April 17, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00609544 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Kidney Disease
Anemia

Intervention ^ICMJE

Drug: Rilonacept

Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks

Study Arm (s)

Experimental: 1
Intervention: Drug: Rilonacept
Placebo Comparator: 2
Intervention: Drug: Rilonacept

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00609544

Other Study ID Numbers ^ICMJE

IL1T-AN-0704

Has Data Monitoring Committee

Responsible Party

Gary Swergold MD, PhD / Medical Director, Regeneron Pharmaceuticals

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

INC Research

Investigators ^ICMJE

Study Director:

Gary Swergold, MD, PhD

Regeneron Pharmaceuticals

Information Provided By

Regeneron Pharmaceuticals

Verification Date

April 2011

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

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