The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

March 21, 2014 updated by: Michael Germain

Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target

Objectives:

  1. Decreased variability of Hgb
  2. Increase the % of patients in target range c Increase in time that Hgb remains target range

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below.

Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.

Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP.

The individual AMP will be utilized weekly during the 9 months of Phase 2.

The 3 objectives will be evaluated and updated weekly, Baseline to Year 1.

All Epo dosing recommendations must be reviewed by the treating physician who can either accept or modify doses at his/her discretion based on clinical event that are not includes in the transmitted data such as bleeding, infection, and hospitalization.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

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
    • Massachusetts
      • Chicopee, Massachusetts, United States, 01013
        • Chicopee Dialysis Center

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:

  • 18 years old or older
  • Receiving hemodialysis in an out-patient dialysis unit

Exclusion Criteria:

  • Not receiving EPOGEN as part of their standard medical care
  • Patient refusal

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized Anemia Mangement Protocol

Single arm study, therefore all patients will participate in the following:

Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.

Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP .
Other: Individualized Anemia Mangement Protocol

Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.

Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraindividual Hemoglobin (Hgb) variability
Time Frame: Evaluated and updated weekly for 52 weeks
Change in average intraindividual Hgb variability between control period and treatment periods.
Evaluated and updated weekly for 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average hemoglobin levels
Time Frame: Evaluated and updated weekly for 52 weeks
Change in average Hgb levels between control treatment periods, and change in interindividual Hgb variability between control treatment periods.
Evaluated and updated weekly for 52 weeks

Collaborators and Investigators

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

Sponsor

Michael Germain

Collaborators

Western New England Renal & Transplant Associates, PC

Investigators

  • Principal Investigator: Michael J Germain, MD, Baystate Medical Center

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, 2013

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

October 29, 2013

First Posted (Estimate)

November 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH-12-197

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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