The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

NCT ID: NCT01975844

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31

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:

1. Decreased variability of Hgb

2. 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.

Conditions

Anemia; End Stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

Individualized Anemia Mangement Protocol

Intervention Type: OTHER

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 .

Interventions

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 .

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western New England Renal & Transplant Associates, PC

OTHER

Sponsor Role: collaborator

Michael Germain

OTHER

Sponsor Role: lead

Responsible Party

Michael Germain

Medical Director, Renal Transplantation, Department of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael J Germain, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center

Locations

Chicopee Dialysis Center

Chicopee, Massachusetts, United States

Countries

United States

Other Identifiers

BH-12-197

Identifier Type: -

Identifier Source: org_study_id