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Study has been terminated due to lack of financial support
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| Name | Class |
|---|---|
| Western New England Renal & Transplant Associates, PC | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Anemia Mangement Protocol | Experimental | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Anemia Mangement Protocol | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Intraindividual Hemoglobin (Hgb) variability | Change in average intraindividual Hgb variability between control period and treatment periods. | Evaluated and updated weekly for 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Germain, MD | Baystate Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicopee Dialysis Center | Chicopee | Massachusetts | 01013 | United States |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
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| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |