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

This study has been completed.
Sponsor:
Collaborator:
Affymax
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01478971
First received: November 22, 2011
Last updated: April 29, 2014
Last verified: April 2014

November 22, 2011
April 29, 2014
October 2011
February 2013   (final data collection date for primary outcome measure)
Percentage of Participants Undergoing Conversion to Peginesatide Injection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of subjects undergoing conversion to peginesatide injection [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01478971 on ClinicalTrials.gov Archive Site
  • Peginesatide Dosing [ Time Frame: Month 6 - 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Peginesatide injection dosing [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Dosing is based on mean dose of Epogen or Peginesatide throughout the study
  • Peginesatide dose deviations [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Based on pre-specified dosing criteria
  • Hemoglobin levels [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with Hgb values within the Hgb range of 10-11 g/dl
  • Iron Utilization [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    Total intravenous iron dose
  • Red Blood Cell Transfusion [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    Percentage of subjects with red blood cell transfusions during the study
Not Provided
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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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]).
Interventions:
  • Drug: Epoetin
  • Drug: Peginesatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01478971
AFX01-18
No
Takeda
Takeda
Affymax
Study Director: Medical Director, Clinical Science Takeda
Takeda
April 2014

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