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

April 2, 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-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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • 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
    • Colorado
      • Lakewood, Colorado, United States
      • Thornton, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • 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
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
      • Macon, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Evergreen Park, Illinois, United States
      • Peoria, Illinois, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Methuen, Massachusetts, United States
      • Plymouth, Massachusetts, United States
      • Springfield, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Flint, Michigan, United States
    • Mississippi
      • Picayune, Mississippi, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New York
      • Great Neck, 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
      • Monroe, North Carolina, United States
    • Ohio
      • Dayton, Ohio, United States
      • Maumee, Ohio, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • 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
    • Texas
      • Arlington, Texas, United States
      • Fountain Valley, Texas, United States
      • Houston, Texas, United States
      • Longview, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Hampton, Virginia, United States
      • Petersburg, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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) >=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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 001
epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Drug: epoetin alfa
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Drug: epoetin alfa
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Drug: epoetin alfa
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Experimental: 003
epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Drug: epoetin alfa
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Drug: epoetin alfa
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Drug: epoetin alfa
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
Experimental: 002
epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Drug: epoetin alfa
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Drug: epoetin alfa
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Drug: epoetin alfa
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
from baseline (Week 1) to the last 12 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)
Time Frame: Weeks 13-37
Weeks 13-37

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)
Time Frame: 36 weeks of treatment
36 weeks of treatment
Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)
Time Frame: 36 weeks of treatment
36 weeks of treatment
Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
Time Frame: 36 weeks of treatment
36 weeks of treatment
Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
Time Frame: 36 weeks of treatment
36 weeks of treatment
Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
Time Frame: 36 weeks of treatment
36 weeks of treatment
Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)
Time Frame: 36 weeks of treatment
36 weeks of treatment
Number of Participants Who Died
Time Frame: 36 weeks of treatment
36 weeks of treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR010414
  • EPOAKD3002

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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