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

Regeneron Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Anemia; Chronic Kidney Disease

Treatments: Drug: Rilonacept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00609544

IL1T-AN-0704

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Rilonacept

2

Placebo Comparator group

Treatment:

Drug: Rilonacept