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
  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: Epoetin
Drug: Peginesatide
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:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants Undergoing Conversion to Peginesatide Injection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  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: 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 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
Takeda
Affymax
Investigators
Study Director: Medical Director, Clinical Science Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01478971     History of Changes
Other Study ID Numbers: AFX01-18
Study First Received: November 22, 2011
Results First Received: February 6, 2014
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Takeda:
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:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014