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

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

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

Interventional

Enrollment (Actual)

430

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

    • 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

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
Intervention / Treatment
Experimental: 001
epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
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
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
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
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk

What is the study measuring?

Primary Outcome Measures

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

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

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.

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.

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

July 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

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)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

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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