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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478971
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : May 26, 2014
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):

November 22, 2011
November 24, 2011
February 6, 2014
May 26, 2014
September 20, 2016
October 2011
February 2013   (Final data collection date for primary outcome measure)
Percentage of Participants Undergoing Conversion to Peginesatide Injection [ Time Frame: 6 months ]
Proportion of subjects undergoing conversion to peginesatide injection [ Time Frame: 13 months ]
Complete list of historical versions of study NCT01478971 on Archive Site
  • 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 ]
  • Peginesatide injection dosing [ Time Frame: 13 months ]
    Dosing is based on mean dose of Epogen or Peginesatide throughout the study
  • Peginesatide Dose Deviations [ Time Frame: 13 months ]
    Based on pre-specified dosing criteria
  • Hemoglobin levels [ Time Frame: 13 months ]
    Percentage of subjects with Hgb values within the Hgb range of 10-11 g/dl
  • Iron Utilization [ Time Frame: 13 months ]
    Total intravenous iron dose
  • Red Blood Cell Transfusion [ Time Frame: 13 months ]
    Percentage of subjects with red blood cell transfusions during the study
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Not Provided
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
A Phase 3b Single-Arm, Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
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.

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.

Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Anemia
  • 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
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
  • Drug: Peginesatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
U1111-1150-2575 ( Registry Identifier: WHO )
Not Provided
Not Provided
Study Director: Medical Director, Clinical Science Takeda
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP