Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Anemia Clinical Trial

— DIAMOND  

Official title:

A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478971
• Other study ID #: AFX01-18
• Secondary ID: U1111-1150-2575
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2011
• Last updated: September 16, 2016
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: September 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Epoetin
Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous [IV] or subcutaneous [SC]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of <11 g/dL.
• Peginesatide
Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at <11 g/dL.

Locations

Country	Name	City	State
United States	Research Facility	North Brunswick	New Jersey
United States	Research Facility	Sacramento	California
United States	Research Facility	San Antonio	Texas
United States	Research Facility	San Diego	California
United States	Research Facility	San Jose	California

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Affymax

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Undergoing Conversion to Peginesatide Injection		6 months	No
Secondary	Peginesatide Dosing	The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.	Month 6 - 12	No
Secondary	Peginesatide Dose Deviations	Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.	Months 6 - 12	No
Secondary	Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL	Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.	Months 1, 2, 3, 4, 5 and 6 of each treatment period	No
Secondary	Percentage of Participants Who Received at Least One Intravenous Iron Dose	Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.	12 months	No
Secondary	Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion		12 months	No