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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 Pharmaceutical Company Limited
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT01478971
First received: November 22, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Anemia
 Drug: peginesatide injection
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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:

U.S. FDA Resources

Further study details as provided by Affymax:

Primary Outcome Measures:
  • Proportion of subjects undergoing conversion to peginesatide injection [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 184
Study Start Date: September 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 Drug: peginesatide injection
Intervention is a once monthly IV or subcutaneous dose of peginesatide injection.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478971

Locations
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
Affymax
Takeda Pharmaceutical Company Limited
Investigators
Study Director: Affymax, Inc. Affymax, Inc.
  More Information

No publications provided

Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT01478971     History of Changes
Other Study ID Numbers: AFX01-18
Study First Received: November 22, 2011
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Affymax:
Anemia
Chronic Renal Failure
CRF
Chronic Kidney Disease
CKD
Erythropoietin
Hematide
 Peginesatide
Hemoglobin
Hgb
Red Blood Cell
Red Blood Cell Production
Dialysis

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
 Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013