The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Anemia Clinical Trial

Official title:

The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01975844
• Other study ID #: BH-12-197
• Status: Terminated
• Phase: Phase 4
• First received: August 13, 2013
• Last updated: March 21, 2014
• Start date: July 2013

Study information

• Verified date: March 2014
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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 .

Locations

Country	Name	City	State
United States	Chicopee Dialysis Center	Chicopee	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Michael Germain	Western New England Renal & Transplant Associates, PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraindividual Hemoglobin (Hgb) variability	Change in average intraindividual Hgb variability between control period and treatment periods.	Evaluated and updated weekly for 52 weeks	Yes
Secondary	Average hemoglobin levels	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	Yes