Status:
WITHDRAWN
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
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Syneos Health
Conditions:
Chronic Kidney Disease
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, ev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00609544
Last Update
April 19 2011
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Alexander City, Alabama, United States
2
Muscle Shoals, Alabama, United States
3
Cerritos, California, United States
4
Long Beach, California, United States