Clinical trial NCT00609544: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Kidney Disease
Anemia
Keywords: Non Dialysis-dependent chronic kidney disease and anemia
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2008-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in blood hemoglobin concentration.
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Alexander City
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Cerritos
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Alampios
country: United States
state: California
city: Thousand Palms
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Lauderdale Lakes
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Blue Ridge
country: United States
state: Georgia
city: Jonesboro
country: United States
state: Georgia
city: Portland
country: United States
state: Maine
city: Queens
country: United States
state: New York
city: Mooresville
country: United States
state: North Carolina
city: Shelby
country: United States
state: North Carolina
city: Allentown
country: United States
state: Pennsylvania
city: Harrisburg
country: United States
state: Pennsylvania
city: Orangeburg
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Barlett
country: United States
state: Tennessee
city: Clarksville
country: United States
state: Tennessee
city: Collierville
country: United States
state: Tennessee
city: Crossville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Ogden
country: United States
state: Utah
city: Falls Church
country: United States
state: Virginia
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Gary Swergold, MD, PhD
role: STUDY_DIRECTOR
References: