Back to resultsConversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis (DIAMOND)
Primary Purpose
Chronic Kidney Disease, Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Epoetin
Peginesatide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Anemia, Chronic Renal Failure, CRF, Chronic Kidney Disease, CKD, Erythropoietin, Hematide, Peginesatide, Hemoglobin, Hgb, Red Blood Cell, Red Blood Cell Production, Dialysis
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
Sites / Locations
- Research Facility
- Research Facility
- Research Facility
- Research Facility
- Research Facility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
peginesatide injection
Arm Description
In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
Outcomes
Primary Outcome Measures
Percentage of Participants Undergoing Conversion to Peginesatide Injection
Secondary Outcome Measures
Peginesatide Dosing
The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.
Peginesatide Dose Deviations
Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.
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.
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.
Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Full Information
NCT ID
NCT01478971
First Posted
November 22, 2011
Last Updated
September 16, 2016
Sponsor
Takeda
Collaborators
Affymax
1. Study Identification
Unique Protocol Identification Number
NCT01478971
Brief Title
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Affymax
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
peginesatide injection
Arm Type
Experimental
Arm Description
In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
Intervention Type
Drug
Intervention Name(s)
Epoetin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginesatide
Other Intervention Name(s)
Omontys
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Undergoing Conversion to Peginesatide Injection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Peginesatide Dosing
Description
The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.
Time Frame
Month 6 - 12
Title
Peginesatide Dose Deviations
Description
Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.
Time Frame
Months 6 - 12
Title
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL
Description
Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.
Time Frame
Months 1, 2, 3, 4, 5 and 6 of each treatment period
Title
Percentage of Participants Who Received at Least One Intravenous Iron Dose
Description
Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.
Time Frame
12 months
Title
Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Research Facility
City
San Diego
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Research Facility
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Research Facility
City
North Brunswick
State/Province
New Jersey
ZIP/Postal Code
08902
Country
United States
Facility Name
Research Facility
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
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