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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Chronic Kidney Disease
• Intervention / Treatment: Drug: Epoetin; Drug: Peginesatide

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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95825
      • Research Facility
    • San Diego, California, United States, 91910
      • Research Facility
    • San Jose, California, United States, 95128
      • Research Facility
  • New Jersey
    • North Brunswick, New Jersey, United States, 08902
      • Research Facility
  • Texas
    • San Antonio, Texas, United States, 78215
      • Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: Omontys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Undergoing Conversion to Peginesatide Injection	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peginesatide Dosing	The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.	Month 6 - 12
Peginesatide Dose Deviations	Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.	Months 6 - 12
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL	Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.	Months 1, 2, 3, 4, 5 and 6 of each treatment period
Percentage of Participants Who Received at Least One Intravenous Iron Dose	Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.	12 months
Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion		12 months

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: Affymax

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Erythropoietin; Anemia; Chronic Kidney Disease; CKD; Chronic Renal Failure; CRF; Hematide; Peginesatide; Hemoglobin; Hgb; Red Blood Cell; Red Blood Cell Production; Dialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hematinics; Epoetin Alfa
• Other Study ID Numbers: AFX01-18; U1111-1150-2575 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No