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

April 22, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Caguas, Puerto Rico
  • United States
    • Arizona
      • Glendale, Arizona, United States
      • Tempe, Arizona, United States
    • California
      • 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
      • Colorado Springs, Colorado, United States
      • Lakewood, Colorado, United States
      • Thornton, Colorado, United States
    • Florida
      • 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
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
      • Carrollton, Georgia, United States
      • Macon, Georgia, United States
      • Statesboro, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Peoria, Illinois, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bethesda, Maryland, United States
    • Massachusetts
      • Methuen, Massachusetts, United States
      • Plymouth, Massachusetts, United States
    • Michigan
      • Flint, Michigan, United States
    • New Jersey
      • Hackensack, New Jersey, United States
      • Old Bridge, New Jersey, United States
      • Vineland, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Great Neck, New York, United States
      • New Hartford, New York, United States
      • New York, New York, United States
      • Springfield Gardens, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greenville, North Carolina, United States
    • Ohio
      • Maumee, Ohio, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Easton, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
    • South Carolina
      • Bamberg, South Carolina, United States
      • Orangeburg, South Carolina, United States
      • Sumter, South Carolina, United States
    • Tennessee
      • Dyersburg, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Fairfax, Virginia, United States
      • Hampton, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIW: Epoetin alfa 3 injections Weekly/Once Weekly
Participants will be administered with epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
Drug: Epoetin alfa 3 times weekly /once weekly
Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks)
Other Names:
  • PROCRIT
Experimental: QW: Epoetin alfa once weekly
Participants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU).
Drug: Epoetin alfa once weekly
Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).
Other Names:
  • PROCRIT
Experimental: Q2W: Epoetin alfa once every two weeks
Participants will be administered with epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU).
Drug: Epoetin alfa once every two weeks
Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).
Other Names:
  • PROCRIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22
Time Frame: From baseline through Week 22
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.
From baseline through Week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9
Time Frame: From baseline to Week 9
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.
From baseline to Week 9

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment
Time Frame: From baseline to Week 22
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.
From baseline to Week 22
Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment
Time Frame: From baseline to Week 22
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.
From baseline to Week 22
Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment
Time Frame: From baseline to Week 22
Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.
From baseline to Week 22
Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment
Time Frame: From baseline to Week 22
Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.
From baseline to Week 22
Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment
Time Frame: From baseline to Week 22
Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.
From baseline to Week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR010411
  • EPOAKD3001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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