Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

NCT01737879 | Terminated Phase 4 Results

• 1 other identifier: 20110209
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 23

Brief Summary

The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Conditions

Anemia

Keywords

Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin

Outcome Measures

Primary Outcomes (1)

• Mean Hemoglobin Concentration During the Evaluation Period

  The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants. No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.

  Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

Secondary Outcomes (3)

• Mean Dose of Epoetin Alfa During the Evaluation Period

  Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).

• Hemoglobin Concentration by Visit

  Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21

• Peginesatide Dose by Visit

  Baseline and Weeks 5, 9, 13, and 17

Study Arms (1)

Peginesatide / Epoetin Alfa

EXPERIMENTAL

Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.

Drug: Peginesatide; Drug: Epoetin alfa

Interventions

Peginesatide DRUG

All participants will receive peginesatide for the first 24 weeks.

Also known as: Omontys

Peginesatide / Epoetin Alfa

Epoetin alfa DRUG

All participants converted to epoetin alfa at week 25 for a total of 32 weeks

Also known as: Epogen

Peginesatide / Epoetin Alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving hemodialysis 3 times a week
• Receiving epoetin alfa IV 3 times a week
• Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening

You may not qualify if:

• Systemic hematologic disease
• Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening

Sponsors & Collaborators

• Amgen: lead

Study Sites (23)

Research Site

Phoenix, Arizona, 85004, United States

Location

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Tempe, Arizona, 85284, United States

Location

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Azusa, California, 91702, United States

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Bakersfield, California, 93309, United States

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Granada Hills, California, 91344, United States

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Los Angeles, California, 90057, United States

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Lynwood, California, 90262, United States

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Paramount, California, 90723, United States

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Riverside, California, 92501, United States

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Whittier, California, 90603, United States

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Orange, Connecticut, 06477, United States

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Meridian, Idaho, 83642, United States

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Kansas City, Missouri, 64111, United States

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Bayonne, New Jersey, 07002, United States

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Amherst, New York, 14221, United States

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Yonkers, New York, 10704, United States

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Winston-Salem, North Carolina, 27103, United States

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Oklahoma City, Oklahoma, 73116, United States

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Orangeburg, South Carolina, 29118, United States

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Dyersburg, Tennessee, 38024, United States

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Jackson, Tennessee, 38305, United States

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Houston, Texas, 77004, United States

Location

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Chesapeake, Virginia, 23320, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

peginesatide; hematide; Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: November 30, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

US (23)