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Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.

Primary Purpose

Anemia, Kidney Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, chronic kidney disease, erythropoetin, Epoetin alfa, erythropoetin recombinant, pre-dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with chronic kidney disease and a glomerular filtration rate within 10-60 ml/min/1.73m2 with no expected need for dialysis during the study subjects with a hemoglobin less than 11 g/dL subjects who have not received erythropoietic agents within 6 weeks before study entry female subjects, with a reproductive potential, must have a negative urine pregnancy test within 7 days of the first dose of study drug. Exclusion Criteria: Subjects with poorly controlled high blood pressure (hypertension) - systolic > 150 mm Hg or diastolic > 100 mm Hg known hypersensitivity to human albumin and/or mammalian cell-derived products subjects receiving dialysis subjects with a ferritin level < 50 ng/mL, Transferrin Saturation < 20% subjects receiving chemotherapy for cancer within 1 month prior to study start or expected during study participation Pregnancy or lactation.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary endpoint is the number of subjects who achieve a hemoglobin response after receiving PROCRIT every 2 weeks. Hemoglobin response is defined as achieving a target hemoglobin range of 11-12 g/dL for at least 2 consecutive weeks by Week 28.

    Secondary Outcome Measures

    The secondary endpoints include: the time to a hemoglobin response, the number of subjects achieving a 1 g/dL rise in hemoglobin, change in quality of life measurements, and the total study drug dose up to the time of response.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    May 19, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho Biotech Products, L.P.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00210743
    Brief Title
    Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.
    Official Title
    An Open-Label, Clinical Evaluation of the Initiation of Every 2 Week Epoetin Alfa (PROCRIT)in the Treatment of Subjects With the Anemia of Chronic Kidney Disease (CKD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Ortho Biotech Products, L.P.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the hemoglobin response rate in subjects with anemia, associated with chronic kidney failure, after receiving epoetin alfa (PROCRIT®) every 2 weeks
    Detailed Description
    This is a prospective study in non-dialysis subjects with anemia associated with chronic kidney disease. Subjects will be enrolled from multiple centers in the United States. The primary objective of the study is to evaluate hemoglobin response rate. The secondary objectives include evaluating the time to when hemoglobin responds, indicated by the results of the hemoglobin blood levels, the change in hemoglobin over time, the transfusion requirements and change in quality of life measurements. These measurements asks for the subjects views about how one feels, activity and energy level, etc. The subjects are administered study drug every 2 weeks through Study Week 27 unless dosing is held or the subject withdraws from the study. Each injection of study drug should not exceed 1 ml in volume.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Kidney Diseases
    Keywords
    Anemia, chronic kidney disease, erythropoetin, Epoetin alfa, erythropoetin recombinant, pre-dialysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    epoetin alfa
    Primary Outcome Measure Information:
    Title
    The primary endpoint is the number of subjects who achieve a hemoglobin response after receiving PROCRIT every 2 weeks. Hemoglobin response is defined as achieving a target hemoglobin range of 11-12 g/dL for at least 2 consecutive weeks by Week 28.
    Secondary Outcome Measure Information:
    Title
    The secondary endpoints include: the time to a hemoglobin response, the number of subjects achieving a 1 g/dL rise in hemoglobin, change in quality of life measurements, and the total study drug dose up to the time of response.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with chronic kidney disease and a glomerular filtration rate within 10-60 ml/min/1.73m2 with no expected need for dialysis during the study subjects with a hemoglobin less than 11 g/dL subjects who have not received erythropoietic agents within 6 weeks before study entry female subjects, with a reproductive potential, must have a negative urine pregnancy test within 7 days of the first dose of study drug. Exclusion Criteria: Subjects with poorly controlled high blood pressure (hypertension) - systolic > 150 mm Hg or diastolic > 100 mm Hg known hypersensitivity to human albumin and/or mammalian cell-derived products subjects receiving dialysis subjects with a ferritin level < 50 ng/mL, Transferrin Saturation < 20% subjects receiving chemotherapy for cancer within 1 month prior to study start or expected during study participation Pregnancy or lactation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17699416
    Citation
    Benz R, Schmidt R, Kelly K, Wolfson M. Epoetin alfa once every 2 weeks is effective for initiation of treatment of anemia of chronic kidney disease. Clin J Am Soc Nephrol. 2007 Mar;2(2):215-21. doi: 10.2215/CJN.02590706. Epub 2007 Jan 10.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=604&filename=CR004600_CSR.pdf
    Description
    An Open-Label, Clinical Evaluation of the Initiation of Every 2 Week PROCRIT (epoetin alfa) in the Treatment of Subjects with the Anemia of Chronic Kidney Disease

    Learn more about this trial

    Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.

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