Clinical trial NCT01737879: Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis
Official title: Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Keywords: Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Hemoglobin Concentration During the Evaluation Period
timeFrame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Secondary outcomes:
measure: Mean Dose of Epoetin Alfa During the Evaluation Period
timeFrame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
measure: Hemoglobin Concentration by Visit
timeFrame: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
measure: Peginesatide Dose by Visit
timeFrame: Baseline and Weeks 5, 9, 13, and 17
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: Azusa
country: United States
facility: Research Site
state: California
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Granada Hills
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Lynwood
country: United States
facility: Research Site
state: California
city: Paramount
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: Connecticut
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Bayonne
country: United States
facility: Research Site
state: New Jersey
city: Amherst
country: United States
facility: Research Site
state: New York
city: Yonkers
country: United States
facility: Research Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: Dyersburg
country: United States
facility: Research Site
state: Tennessee
city: Jackson
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: