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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00609544
• Other study ID #: IL1T-AN-0704
• Status: Withdrawn
• Phase: Phase 2
• First received: December 10, 2007
• Last updated: April 17, 2011

Study information

• Verified date: April 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	INC Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood hemoglobin concentration.		Baseline to Week 12