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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease, Anemia

Intervention / Treatment
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* Drug: Rilonacept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Rilonacept<br>* Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Rilonacept<br>* Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood hemoglobin concentration. |  | Baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Dialysis-dependent chronic kidney disease and anemia