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AnemiaPhase 3NCT00440466

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

A Phase 3 study testing epoetin alfa in people with Anemia and Renal Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 66 sites in United States.

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 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Renal Diseases
What is being tested?
epoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
66 sitesUnited States
Study dates
Jul 2007to Mar 2009
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) >=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.

Who cannot join

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

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Bamberg, South Carolina

  • Study site

    Boston, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Clearwater, Florida

  • Study site

    Columbia, South Carolina

  • Study site

    Dayton, Ohio

  • Study site

    Detroit, Michigan

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Erie, Pennsylvania

  • Study site

    Evergreen Park, Illinois

  • Study site

    Fairfax, Virginia

  • Study site

    Flint, Michigan

  • Study site

    Fountain Valley, California

  • Study site

    Fountain Valley, Texas

  • Study site

    Great Neck, New York

  • Study site

    Greenville, North Carolina

  • Study site

    Hampton, Virginia

  • Study site

    Houston, Texas

  • Study site

    Lakewood, Colorado

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Longview, Texas

  • 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

    Monroe, North Carolina

  • Study site

    New York, New York

  • Study site

    Orange, California

  • Study site

    Orangeburg, South Carolina

  • Study site

    Pembroke Pines, Florida

  • Study site

    Peoria, Illinois

  • Study site

    Petersburg, Virginia

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Picayune, Mississippi

  • Study site

    Plantation, Florida

  • Study site

    Plymouth, Massachusetts

  • Study site

    Providence, Rhode Island

  • Study site

    Richmond, Virginia

  • Study site

    Riverside, California

  • Study site

    Rock Hill, South Carolina

  • Study site

    San Antonio, Texas

  • Study site

    San Dimas, California

  • Study site

    Shreveport, Louisiana

  • Study site

    Springfield, Massachusetts

  • Study site

    Springfield Gardens, New York

  • Study site

    Springhill, Florida

  • Study site

    St Louis, Missouri

  • Study site

    Sumter, South Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Thornton, Colorado

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Hills, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Wynnewood, Pennsylvania

  • Study site

    Yuba City, California

  • Study site

    Zephyrhills, Florida

Other trials in United States

About this study

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

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

Read the 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.

Being tested
epoetin alfa
Keywords
Anemia, Reduction in the number of erythrocytes, Hemoglobin low level, Red blood cell deficiency, Procrit, Epoetin alfa, Chronic kidney disease
Medical subject headings
Anemia, Kidney Diseases, Renal Insufficiency, Chronic

What participants receive

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

  • epoetin alfaDrug

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

  • epoetin alfaDrug

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

  • epoetin alfaDrug

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

Study groups in NCT00440466
Study groupRoleWhat they receive
001Experimentalepoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Receives: Drug: epoetin alfa
003Experimentalepoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Receives: Drug: epoetin alfa
002Experimentalepoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Receives: Drug: epoetin alfa

What is being measured

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

  1. Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment

    Measured: from baseline (Week 1) to the last 12 weeks of treatment

Secondary outcomes (1)

  1. Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)

    Measured: Weeks 13-37

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 startJul 2007
  3. Primary completionMar 2009
  4. Study completionMar 2009

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
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440466
Sponsor's protocol ID
CR010414
Other IDs
EPOAKD3002
Status last verified
Apr 2014
First submitted
26 Feb 2007
Last updated
21 Apr 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing epoetin alfa in people with Anemia and Renal Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 66 sites in United States.

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 4 inclusion and 6 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. 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 14 Apr 2011). 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 Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment (time frame: from baseline (Week 1) to the last 12 weeks of treatment). 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 NCT00440466.

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 21 Apr 2014.

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