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
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 be 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
Clareo Health | 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