PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

NCT ID: NCT00440466

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-03-31

Brief Summary

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Detailed Description

A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

Conditions

Anemia; Renal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks

Group Type: EXPERIMENTAL

epoetin alfa

Intervention Type: DRUG

Continue pre-study once weekly dose of epoetin alfa for 36 weeks

003

epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Group Type: EXPERIMENTAL

epoetin alfa

Intervention Type: DRUG

Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

002

epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

Group Type: EXPERIMENTAL

epoetin alfa

Intervention Type: DRUG

Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

Interventions

epoetin alfa

Continue pre-study once weekly dose of epoetin alfa for 36 weeks

Intervention Type: DRUG

epoetin alfa

Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks

Intervention Type: DRUG

epoetin alfa

Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) >=15 mL/min per 1.73 m2 and <60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
• Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization
• History of increase in hemoglobin after the initial dose
• Stable dose of epoetin alfa given once-weekly before randomization.

Exclusion Criteria

• Uncontrolled hypertension
• Iron deficiency
• iron overload
• severe congestive heart failure
• Active infection
• Recent heart attack, Stroke or blood clot.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Chula Vista, California, United States

Fountain Valley, California, United States

Los Angeles, California, United States

Lynwood, California, United States

Orange, California, United States

Riverside, California, United States

San Dimas, California, United States

West Hills, California, United States

Yuba City, California, United States

Lakewood, Colorado, United States

Thornton, Colorado, United States

Washington D.C., District of Columbia, United States

Clearwater, Florida, United States

Miami, Florida, United States

Pembroke Pines, Florida, United States

Plantation, Florida, United States

Springhill, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Zephyrhills, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Macon, Georgia, United States

Chicago, Illinois, United States

Evergreen Park, Illinois, United States

Peoria, Illinois, United States

Shreveport, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Methuen, Massachusetts, United States

Plymouth, Massachusetts, United States

Springfield, Massachusetts, United States

Detroit, Michigan, United States

Flint, Michigan, United States

Picayune, Mississippi, United States

St Louis, Missouri, United States

Great Neck, New York, United States

New York, New York, United States

Springfield Gardens, New York, United States

Charlotte, North Carolina, United States

Greenville, North Carolina, United States

Monroe, North Carolina, United States

Dayton, Ohio, United States

Maumee, Ohio, United States

Allentown, Pennsylvania, United States

Doylestown, Pennsylvania, United States

Erie, Pennsylvania, United States

Lancaster, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Providence, Rhode Island, United States

Bamberg, South Carolina, United States

Columbia, South Carolina, United States

Orangeburg, South Carolina, United States

Rock Hill, South Carolina, United States

Sumter, South Carolina, United States

Arlington, Texas, United States

Fountain Valley, Texas, United States

Houston, Texas, United States

Longview, Texas, United States

San Antonio, Texas, United States

Fairfax, Virginia, United States

Hampton, Virginia, United States

Petersburg, Virginia, United States

Richmond, Virginia, United States

Tacoma, Washington, United States

Countries

United States

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=58&filename=CR010414_CSR.pdf

A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, with Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects with Chronic Kidney Disease

Other Identifiers

EPOAKD3002

Identifier Type: -

Identifier Source: secondary_id

CR010414

Identifier Type: -

Identifier Source: org_study_id