A Study to Assess Disability in Anemic Elderly Patients With Kidney Disease Receiving PROCRIT (Epoetin Alfa)

May 17, 2011 updated by: Ortho Biotech Products, L.P.

An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients With Chronic Kidney Disease Receiving PROCRIT (Epoetin Alfa)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

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

Sponsor

Ortho Biotech Products, L.P.

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

November 1, 2003

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

June 16, 2006

First Submitted That Met QC Criteria

June 16, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004606

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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