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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Anemia

In brief

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.

Key facts

Study ID

NCT00609544

Run by

Regeneron Pharmaceuticals

People needed

0

Last updated by the study team

2011-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Alexander City, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Cerritos, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Alampios, California, United States
• Study site — Thousand Palms, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Blue Ridge, Georgia, United States
• Study site — Jonesboro, Georgia, United States
• Study site — Portland, Maine, United States
• Study site — Queens, New York, United States
• Study site — Mooresville, North Carolina, United States
• Study site — Shelby, North Carolina, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Harrisburg, Pennsylvania, United States
• Study site — Orangeburg, South Carolina, United States
• Study site — Sumter, South Carolina, United States
• Study site — Barlett, Tennessee, United States
• Study site — Clarksville, Tennessee, United States
• Study site — Collierville, Tennessee, United States
• Study site — Crossville, Tennessee, United States
• Study site — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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