Clinical trial NCT01478971: Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
Official title: A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Anemia
Keywords: Anemia
Chronic Renal Failure
CRF
Chronic Kidney Disease
CKD
Erythropoietin
Hematide
Peginesatide
Hemoglobin
Hgb
Red Blood Cell
Red Blood Cell Production
Dialysis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Affymax
First posted: 2011-11-24
Enrollment: 184
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 understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.

Detailed description: Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patients. Because of the differences in the processes needed to support monthly dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate factors in the dialysis environment during center-level transition of patients from one ESA to another.

AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5 hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period was approximately 12 months in duration. Participants received peginesatide injection for approximately six months.

Eligibility criteria: Inclusion Criteria:

* Have provided written informed consent in accordance with institutional, local, and national guidelines
* Are ≥18 years of age at the start of screening
* Have been on in-center hemodialysis for ≥12 weeks at the start of screening
* Are currently maintained on Epoetin at the start of screening
* If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study
* If a female of childbearing potential, have a negative pregnancy test during screening

Exclusion Criteria:

* Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.)
* Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.)
* Have known intolerance to any ESA or PEGylated molecule
* Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study
* Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance
* Are pregnant or nursing

Primary outcomes:
measure: Percentage of Participants Undergoing Conversion to Peginesatide Injection
timeFrame: 6 months
Secondary outcomes:
measure: Peginesatide Dosing
timeFrame: Month 6 - 12
measure: Peginesatide Dose Deviations
timeFrame: Months 6 - 12
measure: Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL
timeFrame: Months 1, 2, 3, 4, 5 and 6 of each treatment period
measure: Percentage of Participants Who Received at Least One Intravenous Iron Dose
timeFrame: 12 months
measure: Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
timeFrame: 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: San Jose
country: United States
facility: Research Facility
state: California
city: North Brunswick
country: United States
facility: Research Facility
state: New Jersey
city: San Antonio
country: United States
facility: Research Facility
state: Texas
Study officials:
affiliation: Takeda
name: Medical Director, Clinical Science
role: STUDY_DIRECTOR
References: