search
Back to results

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

Primary Purpose

Chronic Kidney Disease, Anemia

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rilonacept
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Non Dialysis-dependent chronic kidney disease and anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change in blood hemoglobin concentration.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2007
Last Updated
April 17, 2011
Sponsor
Regeneron Pharmaceuticals
Collaborators
Syneos Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00609544
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll patients
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Syneos Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Anemia
Keywords
Non Dialysis-dependent chronic kidney disease and anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rilonacept
Intervention Description
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
Primary Outcome Measure Information:
Title
Change in blood hemoglobin concentration.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Swergold, MD, PhD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Alexander City
State/Province
Alabama
Country
United States
City
Muscle Shoals
State/Province
Alabama
Country
United States
City
Cerritos
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Los Alampios
State/Province
California
Country
United States
City
Thousand Palms
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Lauderdale Lakes
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Blue Ridge
State/Province
Georgia
Country
United States
City
Jonesboro
State/Province
Georgia
Country
United States
City
Portland
State/Province
Maine
Country
United States
City
Queens
State/Province
New York
Country
United States
City
Mooresville
State/Province
North Carolina
Country
United States
City
Shelby
State/Province
North Carolina
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Harrisburg
State/Province
Pennsylvania
Country
United States
City
Orangeburg
State/Province
South Carolina
Country
United States
City
Sumter
State/Province
South Carolina
Country
United States
City
Barlett
State/Province
Tennessee
Country
United States
City
Clarksville
State/Province
Tennessee
Country
United States
City
Collierville
State/Province
Tennessee
Country
United States
City
Crossville
State/Province
Tennessee
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Ogden
State/Province
Utah
Country
United States
City
Falls Church
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs