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The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Primary Purpose

Anemia, End Stage Renal Disease

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Individualized Anemia Mangement Protocol

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, End Stage Renal Disease

Eligibility Criteria

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

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

Sites / Locations

Chicopee Dialysis Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individualized Anemia Mangement Protocol

Arm Description

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 .

Outcomes

Primary Outcome Measures

Intraindividual Hemoglobin (Hgb) variability

Change in average intraindividual Hgb variability between control period and treatment periods.

Secondary Outcome Measures

Average hemoglobin levels

Change in average Hgb levels between control treatment periods, and change in interindividual Hgb variability between control treatment periods.

Full Information

NCT ID

NCT01975844

First Posted

August 13, 2013

Last Updated

March 21, 2014

Sponsor

Michael Germain

Collaborators

Western New England Renal & Transplant Associates, PC

1. Study Identification

Unique Protocol Identification Number

NCT01975844

Brief Title

The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Official Title

The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Why Stopped

Study has been terminated due to lack of financial support

Study Start Date

July 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Germain

Collaborators

Western New England Renal & Transplant Associates, PC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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: Decreased variability of Hgb Increase the % of patients in target range c Increase in time that Hgb remains target range

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, End Stage Renal Disease

Keywords

Anemia, End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individualized Anemia Mangement Protocol

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Individualized Anemia Mangement Protocol

Intervention Description

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 .

Primary Outcome Measure Information:

Title

Intraindividual Hemoglobin (Hgb) variability

Description

Change in average intraindividual Hgb variability between control period and treatment periods.

Time Frame

Evaluated and updated weekly for 52 weeks

Secondary Outcome Measure Information:

Title

Average hemoglobin levels

Description

Change in average Hgb levels between control treatment periods, and change in interindividual Hgb variability between control treatment periods.

Time Frame

Evaluated and updated weekly for 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Germain, MD

Organizational Affiliation

Baystate Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chicopee Dialysis Center

City

Chicopee

State/Province

Massachusetts

ZIP/Postal Code

01013

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

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