Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

Anemia Clinical Trial

Official title:

Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01737879
• Other study ID #: 20110209
• Status: Terminated
• Phase: Phase 4
• First received: October 3, 2012
• Last updated: March 14, 2014
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Amgen
• 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

The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Description:

This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Receiving hemodialysis 3 times a week

• Receiving epoetin alfa IV 3 times a week

• Hemoglobin concentration = 9.0 and = 12.0 g/dL within 8 weeks of or during screening

Key Exclusion Criteria:

• Systemic hematologic disease

• Changes in Epoetin alfa dose by = 50% within 8 weeks of or during screening

Study Design

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Peginesatide
All participants will receive peginesatide for the first 24 weeks.
• Epoetin alfa
All participants converted to epoetin alfa at week 25 for a total of 32 weeks

Locations

Country	Name	City	State
United States	Research Site	Amherst	New York
United States	Research Site	Azusa	California
United States	Research Site	Bakersfield	California
United States	Research Site	Bayonne	New Jersey
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Dyersburg	Tennessee
United States	Research Site	Granada Hills	California
United States	Research Site	Houston	Texas
United States	Research Site	Jackson	Tennessee
United States	Research Site	Kansas City	Missouri
United States	Research Site	Los Angeles	California
United States	Research Site	Lynwood	California
United States	Research Site	Meridian	Idaho
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	Connecticut
United States	Research Site	Orangeburg	South Carolina
United States	Research Site	Paramount	California
United States	Research Site	Phoenix	Arizona
United States	Research Site	Riverside	California
United States	Research Site	Tempe	Arizona
United States	Research Site	Whittier	California
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Yonkers	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Hemoglobin Concentration During the Evaluation Period	The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.; No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.	Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).	No
Secondary	Mean Dose of Epoetin Alfa During the Evaluation Period	No participant reached the evaluation period, therefore, this endpoint could not be evaluated.	Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).	No
Secondary	Hemoglobin Concentration by Visit		Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21	No
Secondary	Peginesatide Dose by Visit		Baseline and Weeks 5, 9, 13, and 17	No

External Links

•   AmgenTrials clinical trials website