The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

NCT01975844 | Terminated Phase 4 DMC

• 1 other identifier: BH-12-197
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 1.Decreased variability of Hgb
2. 2.Increase the % of patients in target range c Increase in time that Hgb remains target range

Conditions

Anemia; End Stage Renal Disease

Keywords

Anemia; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Intraindividual Hemoglobin (Hgb) variability

  Change in average intraindividual Hgb variability between control period and treatment periods.

  Evaluated and updated weekly for 52 weeks

Secondary Outcomes (1)

• Average hemoglobin levels

  Evaluated and updated weekly for 52 weeks

Study Arms (1)

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 .

Other: Individualized Anemia Mangement Protocol

Interventions

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 .

Individualized Anemia Mangement Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Receiving hemodialysis in an out-patient dialysis unit

You may not qualify if:

• Not receiving EPOGEN as part of their standard medical care
• Patient refusal

Sponsors & Collaborators

• Michael Germain: lead
• Western New England Renal & Transplant Associates, PC: collaborator

Study Sites (1)

Chicopee Dialysis Center

Chicopee, Massachusetts, 01013, United States

Location

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J Germain, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Renal Transplantation, Department of Medicine

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: November 5, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

US (1)