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AnemiaPhase 3NCT00440557

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

A Phase 3 study testing Epoetin alfa 3 times weekly /once weekly, Epoetin alfa once weekly and Epoetin alfa once every two weeks in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 62 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Epoetin alfa 3 times weekly /once weekly, Epoetin alfa once weekly and Epoetin alfa once every two weeks
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
62 sitesin 2 countries
Study dates
Sep 2006to Feb 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Uncontrolled hypertension
  • Serum ferritin level less than 50 ng/mL
  • Serum iron overload
  • Severe congestive heart failure
  • Active infection

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States61 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Bamberg, South Carolina

  • Study site

    Bethesda, Maryland

  • Study site

    Carrollton, Georgia

  • Study site

    Charlotte, North Carolina

  • Study site

    Chesapeake, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Colorado Springs, Colorado

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Dyersburg, Tennessee

  • Study site

    Easton, Pennsylvania

  • Study site

    Erie, Pennsylvania

  • Study site

    Fairfax, Virginia

  • Study site

    Flint, Michigan

  • Study site

    Glendale, Arizona

  • Study site

    Great Neck, New York

  • Study site

    Greenville, North Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Hampton, Virginia

  • Study site

    Houston, Texas

  • Study site

    Lakewood, Colorado

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lauderdale Lakes, Florida

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Lynwood, California

  • Study site

    Macon, Georgia

  • Study site

    Maumee, Ohio

  • Study site

    Methuen, Massachusetts

  • Study site

    Miami, Florida

  • Study site

    New Hartford, New York

  • Study site

    New York, New York

  • Study site

    Old Bridge, New Jersey

  • Study site

    Orangeburg, South Carolina

  • Study site

    Orlando, Florida

  • Study site

    Palm Beach Gardens, Florida

  • Study site

    Peoria, Illinois

  • Study site

    Plymouth, Massachusetts

  • Study site

    Richmond, Virginia

  • Study site

    Riverside, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Springfield Gardens, New York

  • Study site

    Statesboro, Georgia

  • Study site

    Sumter, South Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Thornton, Colorado

  • Study site

    Vineland, New Jersey

  • Study site

    Visalia, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Whittier, California

  • Study site

    Wynnewood, Pennsylvania

  • Study site

    Yuba City, California

  • Study site

    Zephyrhills, Florida

Other trials in United States

Puerto Rico1 site

  • Study site

    Caguas

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Conditions
Anemia
Being tested
Epoetin alfa 3 times weekly /once weekly, Epoetin alfa once weekly, Epoetin alfa once every two weeks
Keywords
Anemia, Chronic Kidney disease, Kidney disease, Epoetin alfa, Procrit
Medical subject headings
Anemia, Renal Insufficiency, Chronic, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epoetin alfa 3 times weekly /once weeklyDrug

    Also called PROCRIT

    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)

  • Epoetin alfa once weeklyDrug

    Also called PROCRIT

    Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).

  • Epoetin alfa once every two weeksDrug

    Also called PROCRIT

    Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).

Study groups in NCT00440557
Study groupRoleWhat they receive
TIW: Epoetin alfa 3 injections Weekly/Once WeeklyExperimentalParticipants 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)
Receives: Drug: Epoetin alfa 3 times weekly /once weekly
QW: Epoetin alfa once weeklyExperimentalParticipants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU).
Receives: Drug: Epoetin alfa once weekly
Q2W: Epoetin alfa once every two weeksExperimentalParticipants will be administered with epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU).
Receives: Drug: Epoetin alfa once every two weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment 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.

    Measured: From baseline through Week 22

Secondary outcomes (1)

  1. Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by 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.

    Measured: From baseline to Week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2007 (estimated)
  2. Study startSep 2006
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440557
Sponsor's protocol ID
CR010411
Other IDs
EPOAKD3001
Status last verified
Apr 2014
First submitted
26 Feb 2007
Last updated
7 May 2014
Data monitoring committee
Yes

Publications

  • Pergola PE, Gartenberg G, Fu M, Wolfson M, Rao S, Bowers P. A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia. Clin J Am Soc Nephrol. 2009 Nov;4(11):1731-40. doi: 10.2215/CJN.03470509. Epub 2009 Sep 17.

    PubMed 19808215

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epoetin alfa 3 times weekly /once weekly, Epoetin alfa once weekly and Epoetin alfa once every two weeks in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 62 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00440557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.

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