An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

Condition(s) targeted: Anemia

Intervention: Epoetin alfa 3 times weekly /once weekly (Drug); Epoetin alfa once weekly (Drug); Epoetin alfa once every two weeks (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.

Official title: A Randomized, Open Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens, Once-Weekly and Every-Two-Weeks, With the Three-Times-Weekly Dosing Regimen for Initiation and Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22

Secondary outcome: Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9

Detailed description: This is a open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study designed to show that 2 alternative dosing regimens, once weekly and once every-2-weeks (given at doses equivalent to 50 IU/kg 3 times a week) are not inferior to the 3-times-weekly dosing regimen. Approximately 375 patients with anemia will be enrolled in this study. Patients will be randomly assigned to receive epoetin alfa by subcutaneous (SC) injection according to one of the following 3 regimens: 3 times weekly (Group 1), once weekly (Group 2), or once every 2 weeks (Group 3) for 22 weeks. Thereafter, patients in Group 1 will be switched to the once-weekly dosing regimen for an additional 22 weeks, and patients in Groups 2 and 3 will continue their current treatment for an additional 22 weeks. The total duration of the open-label treatment phase is 44 weeks which will include initiation and maintenance treatment periods (with the goal of increasing, then maintaining, the hemoglobin level between 11. 0 and 11. 9 g/dL inclusive) and a safety period (to assess longer exposure to epoetin alfa treatment and any period of hemoglobin instability during the transition from 3-times-weekly to once-weekly dosing). Starting doses of epoetin alfa in the 3-times-weekly, once-weekly, and every-2-weeks groups will be 50 IU/kg, 10,000 IU, and 20,000 IU, respectively; thereafter adjusted according to weekly hemoglobin concentrations. Safety evaluations will include assessment of adverse events, laboratory tests, physical examinations, and vital signs.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular

filtration rate (GFR) more than or equal to 15 mL/min per 1. 73 m2 and less than 60 mL/min per 1. 73 m2 (Stages 3 and 4) as calculated by the central laboratory

- Require support of an erythropoietin receptor agonist

Exclusion Criteria:

- Uncontrolled hypertension

- Serum ferritin level less than 50 ng/mL

- Serum iron overload

- Severe congestive heart failure

- Active infection

Caguas, Puerto Rico

Glendale, Arizona, United States

Tempe, Arizona, United States

Chula Vista, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Lynwood, California, United States

Riverside, California, United States

San Diego, California, United States

Visalia, California, United States

Whittier, California, United States

Yuba City, California, United States

Colorado Springs, Colorado, United States

Lakewood, Colorado, United States

Thornton, Colorado, United States

Lauderdale Lakes, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Palm Beach Gardens, 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

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Chicago, Illinois, United States

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Old Bridge, New Jersey, United States

Vineland, New Jersey, United States

Albuquerque, New Mexico, United States

Great Neck, New York, United States

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New York, New York, United States

Springfield Gardens, New York, United States

Charlotte, North Carolina, United States

Greenville, North Carolina, United States

Maumee, Ohio, United States

Doylestown, Pennsylvania, United States

Easton, Pennsylvania, United States

Erie, Pennsylvania, United States

Lancaster, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Bamberg, South Carolina, United States

Orangeburg, South Carolina, United States

Sumter, South Carolina, United States

Dyersburg, Tennessee, United States

Arlington, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Chesapeake, Virginia, United States

Fairfax, Virginia, United States

Hampton, Virginia, United States

Richmond, Virginia, United States

Tacoma, Washington, United States

A Randomized,Open-Label, Multicenter Study of Epoetin Alfa Comparing Two Extended-Dosing Regimens,OnceWeekly and EveryTwoWeeks,With the ThreeTimesWeekly Dosing Regimen for Initiation & Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease

Starting date: September 2006
Last updated: April 22, 2014