NCT00609544

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Anemia

Interventions

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

Timeline

• First posted: 2008-02-07
• Last updated: 2011-04-19

Locations

27 sites across 1 country: United States