Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Takeda Identifier:
First received: November 22, 2011
Last updated: September 16, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Chronic Kidney Disease
Drug: Epoetin
Drug: Peginesatide
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants Undergoing Conversion to Peginesatide Injection [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Peginesatide Dosing [ Time Frame: Month 6 - 12 ]
    The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.

  • Peginesatide Dose Deviations [ Time Frame: Months 6 - 12 ]
    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 [ Time Frame: Months 1, 2, 3, 4, 5 and 6 of each treatment period ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]

Enrollment: 184
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peginesatide injection
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]).
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.
Drug: 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.
Other Name: Omontys

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01478971

United States, California
Research Facility
Sacramento, California, United States, 95825
Research Facility
San Diego, California, United States, 91910
Research Facility
San Jose, California, United States, 95128
United States, New Jersey
Research Facility
North Brunswick, New Jersey, United States, 08902
United States, Texas
Research Facility
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Study Director: Medical Director, Clinical Science Takeda
  More Information

Responsible Party: Takeda Identifier: NCT01478971     History of Changes
Other Study ID Numbers: AFX01-18
U1111-1150-2575 ( Registry Identifier: WHO )
Study First Received: November 22, 2011
Results First Received: February 6, 2014
Last Updated: September 16, 2016

Keywords provided by Takeda:
Chronic Renal Failure
Chronic Kidney Disease
Red Blood Cell
Red Blood Cell Production

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Epoetin Alfa
Hematinics processed this record on April 26, 2017