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:
Takeda
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT01478971
First received: November 22, 2011
Last updated: March 8, 2013
Last verified: March 2013

November 22, 2011
March 8, 2013
September 2011
February 2013   (final data collection date for primary outcome measure)
Proportion of subjects undergoing conversion to peginesatide injection [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01478971 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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 will be conducted at 1-5 hemodialysis sites in the United States, and will enroll Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period is intended to be approximately 12 months in duration. Subjects will receive 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: peginesatide injection
Intervention is a once monthly IV or subcutaneous dose of peginesatide injection.
Experimental: peginesatide injection
Intervention: Drug: peginesatide injection
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: Subjects 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: Subjects 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
Affymax
Affymax
Takeda
Study Director: Affymax, Inc. Affymax, Inc.
Affymax
March 2013

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