The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

NCT01975844 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-03-26

No results posted yet for this study

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

Conditions

Interventions

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 .

Sponsors & Collaborators

  • Western New England Renal & Transplant Associates, PC

    collaborator OTHER
  • Michael Germain

    lead OTHER

Principal Investigators

  • Michael J Germain, MD · Baystate Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975844 on ClinicalTrials.gov