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

NCT ID: NCT01478971

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-02-28

Brief Summary

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.

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.

Conditions

Chronic Kidney Disease; Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 \[PTP\]).

Group Type: EXPERIMENTAL

Epoetin

Intervention Type: DRUG

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.

Peginesatide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Omontys

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affymax

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Research Facility

Sacramento, California, United States

Research Facility

San Diego, California, United States

Research Facility

San Jose, California, United States

Research Facility

North Brunswick, New Jersey, United States

Research Facility

San Antonio, Texas, United States

Countries

United States

Other Identifiers

U1111-1150-2575

Identifier Type: REGISTRY

Identifier Source: secondary_id

AFX01-18

Identifier Type: -

Identifier Source: org_study_id