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
NCT ID: NCT00609544
Last Updated: 2011-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of LY3819469 in Participants With Impaired and Normal Renal Function
NCT05841277
A Study of LY3113593 in Participants With Chronic Kidney Disease
NCT02604160
A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis
NCT02144285
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT01906489
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
NCT01381094
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Rilonacept
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
2
Rilonacept
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rilonacept
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Syneos Health
OTHER
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Regeneron Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gary Swergold, MD, PhD
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alexander City, Alabama, United States
Muscle Shoals, Alabama, United States
Cerritos, California, United States
Long Beach, California, United States
Los Alampios, California, United States
Thousand Palms, California, United States
Colorado Springs, Colorado, United States
Lauderdale Lakes, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Blue Ridge, Georgia, United States
Jonesboro, Georgia, United States
Portland, Maine, United States
Queens, New York, United States
Mooresville, North Carolina, United States
Shelby, North Carolina, United States
Allentown, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Orangeburg, South Carolina, United States
Sumter, South Carolina, United States
Barlett, Tennessee, United States
Clarksville, Tennessee, United States
Collierville, Tennessee, United States
Crossville, Tennessee, United States
Memphis, Tennessee, United States
Ogden, Utah, United States
Falls Church, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IL1T-AN-0704
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.