Anemia, End Stage Renal Disease
Conditions
Keywords
Anemia, End Stage Renal Disease
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.
Interventions
OTHERIndividualized 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
Western New England Renal & Transplant Associates, PC
Michael Germain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraindividual Hemoglobin (Hgb) variability | Evaluated and updated weekly for 52 weeks | Change in average intraindividual Hgb variability between control period and treatment periods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average hemoglobin levels | Evaluated and updated weekly for 52 weeks | Change in average Hgb levels between control treatment periods, and change in interindividual Hgb variability between control treatment periods. |
Countries
United States
Outcome results
None listed