The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Michael Germain

Status and phase: Terminated; Phase 4

Conditions: Anemia; End Stage Renal Disease

Treatments: Other: Individualized Anemia Mangement Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01975844

BH-12-197

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Individualized Anemia Mangement Protocol

Experimental group

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 .

Treatment:

Other: Individualized Anemia Mangement Protocol