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A Study to Assess Disability in Anemic Elderly Patients With Kidney Disease Receiving PROCRIT® (Epoetin Alfa)
This study has been terminated.
Sponsored by: Ortho Biotech Products, L.P.
Information provided by: Ortho Biotech, Inc.
ClinicalTrials.gov Identifier: NCT00338468
  Purpose

The purpose of this study is to assess disability in anemic patients over the age of 65 who have kidney disease and are receiving weekly PROCRIT® (Epoetin Alfa, a glycoprotein that stimulates red blood cell production).


Condition Intervention Phase
Kidney Diseases
Anemia
Drug: epoetin alfa
Phase IV

MedlinePlus related topics: Anemia
Drug Information available for: Epoetin alfa Erythropoietin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients With Chronic Kidney Disease Receiving PROCRIT® (Epoetin Alfa)

Further study details as provided by Ortho Biotech, Inc.:

Primary Outcome Measures:
  • Change in physical function score as measured by the Six Minute Walk Test (6MWT) and Short Physical Performance (SPP) Summary Score compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.

Secondary Outcome Measures:
  • Proportion of patients who achieve the target hemoglobin levels of > 13.0 g/dL and < =14.0 g/dL (independent of transfusion within 1 month of assessment) compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.

Estimated Enrollment: 30
Study Start Date: November 2003
Study Completion Date: September 2005
Detailed Description:

This is an open-label study in which PROCRIT® (Epoetin Alfa) will be given on a weekly basis starting at a dose lower than is currently approved by the U.S. FDA because treatment is beginning at a higher hemoglobin than usual. There is recent evidence to suggest that problems with disability occur in persons over 65 at higher hemoglobins than previously recognized. Currently, PROCRIT® (Epoetin Alfa) is prescribed for patients with chronic kidney disease three times a week at a dose of approximately 5,000 and 10,000 units per injection depending on the patient's weight. This study is starting with a lower dose because treatment is beginning earlier than it normally would. Currently, doctors usually do not begin PROCRIT® (Epoetin Alfa) in patients with chronic kidney disease until their hemoglobin is <10 g/dL. In this study PROCRIT® (Epoetin Alfa) will be given on a weekly basis starting at 5,000 units per injection if hemoglobin is <12 g/dL. Each week hemoglobin will be checked and if after four weeks of treatment it is < 13 g/dL, the PROCRIT® (Epoetin Alfa) dose will be increased to 10,000 Units. After another four weeks of treatment if the hemoglobin is <13 g/dL, PROCRIT® (Epoetin Alfa) will be increased to 20,000 units. After another four weeks of treatment if the hemoglobin is <13 g/dL, PROCRIT® (Epoetin Alfa) will be increased once more to a final dose of 40,000 units. In this study, patients will be treated with doses higher than currently approved for patients with chronic kidney disease. The primary measures of efficacy will be assessed using two disability tests to measure physical function compared from baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up. The first test is called the "Short Physical Performance Battery" (SPP) which will test how well someone sits, stands and walks. The second test is called the "Six Minute Walk Test" (6MWT) which measures how far someone can walk during a six-minute period. Normal walking aids are allowed during this test. The study will also evaluate hemoglobin levels, number of transfusions, safety, incidence of anti-erythropoietin antibodies, Quality of Life and cognitive function (a measure of how clearly one is thinking). The study hypothesis is that physical function will improve when the hemoglobin level is increased.

Patients will receive PROCRIT® (Epoetin Alfa) on a weekly basis starting at 5,000 units per injection (up to a maximum of 40,000 units).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having chronic anemia and chronic renal failure
  • Have lessened physical function
  • Be community dwelling (defined as not admitted to an assisted nursing facility, nursing home or hospital at the time of enrollment. An assisted nursing facility is considered any living situation where daily care is being provided by recognized health care professionals from that facility.)

Exclusion Criteria:

  • History of bacterial infection requiring hospitalization and intravenous antibiotics or transfusion within 1 month prior to enrollment
  • Anemia due to iron, folate, or vitamin B12 deficiency
  • Gastrointestinal bleeding
  • Anticipated to begin dialysis within 4 months following enrollment into the study
  • History of thrombotic disease within the past 3 months, or on anticoagulation therapy at enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338468

Sponsors and Collaborators
Ortho Biotech Products, L.P.
Investigators
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech, Inc.
  More Information

An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients with Chronic Kidney Disease Receiving PROCRIT (Epoetin alfa)  This link exits the ClinicalTrials.gov site
For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/  This link exits the ClinicalTrials.gov site
Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Study ID Numbers: CR004606
Study First Received: June 16, 2006
Last Updated: June 29, 2007
ClinicalTrials.gov Identifier: NCT00338468  
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho Biotech, Inc.:
Anemia
Elderly
Chronic Kidney Disease
Hemoglobin level

Study placed in the following topic categories:
Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009