Trial Information

Summary: 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

The primary objective of the study is to assess the effect of rilonacept on hemoglobin levels in inflamed anemic subjects with non dialysis-dependent chronic kidney disease (NDD-CKD), with or without concurrent treatment with recombinant human erythropoietin (rHuEPO).

Patient Inclusion Criteria:

1. age greater than or equal to 18 years
2. CKD not yet requiring renal replacement therapy (pre-dialysis patients) as evidenced by estimated glomerular filtration rate (eGFR) great than or equal to 15mL/min and less than 60 mL/min.
3. not expected to require dialysis during the duration of the study
4. blood hemoglobin greater than 8g/dL and less than or equal to 10.5 g/dL
5. adequate iron stores as defined by serum ferritin greater than 100 ng/mL
6. able to understand and willing to sign informed consent form
7. able to read, understand and complete study-related questionnaires
8. willingness to utilize adequate contraception (for men and women of childbearing potential)

9. Patient Exclusion Criteria:

   • persitent chronic or active infections requiring treatment with IV antibiotics, IV antivirals, or IV antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to the Screening Visit
   • use of biological agents other than rHuEPO for the duration of the study
   • Any uncontrolled active major systemic disorder
   • IV iron administration within 12 weeks prior to the Screening Visit
   • prior recipient or scheduled to receive a kidney transplant during the study
   • history or presence of malignancy within 5 years prior to Screening Visit (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix)
   • systemic or IA corticosteroid use within 60 days prior to Screening Visit
   • history of HIV infection by clinical or serological history
   • known history of severe uncontrolled hyperparathyroidism defined as intact PTH greater than 1500 pg/mL
   • coronary disease diagnosed in the 3 months prior to the Screening Visit
   • history of thromboembolic event within 2 years of the screening visit
   • red blood cell (RBC) transfusions within 8 weeks prior to the Screening Visit

If you would like to learn more about participating in this study, please send an e-mail message using the form below.