Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

NCT02253654 | Completed Phase 4 Results

• 1 other identifier: 20110208
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 37

Brief Summary

The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis.

Conditions

Renal Insufficiency, Chronic; Anemia; Renal Dialysis; Erythrocyte Transfusion

Keywords

Chronic Kidney Disease; Anemia; Hemodialysis; Red Blood Cell Transfusion

Outcome Measures

Primary Outcomes (1)

• Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period

  Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.

  The evaluation period (weeks 13-37)

Secondary Outcomes (7)

• Hemoglobin Concentration at Each Visit

  Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

• Percentage of Participants With Transfusion Events Overall and During Each Study Period

  Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

• Hemoglobin Rate of Change at Each Visit

  Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

• Hemoglobin Intra-subject Variability

  The evaluation period (weeks 13 to 37)

• Percentage of Participants With Hemoglobin Excursions at Each Visit

  Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37

Study Arms (2)

Epoetin alfa Alternative Titration

EXPERIMENTAL

Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.

Drug: Epoetin alfa

Epoetin alfa USPI Titration

ACTIVE COMPARATOR

Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.

Drug: Epoetin alfa

Interventions

Epoetin alfa DRUG

Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.

Also known as: Epogen

Epoetin alfa Alternative Titration; Epoetin alfa USPI Titration

Eligibility Criteria

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

You may qualify if:

• Informed consent obtained prior to initiation of any study-specific activities/procedures
• Age 18 or older
• Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization
• Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization
• Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and \< 90,000 Units/week (ie, \< 30,000 Units/administration) of epoetin alfa during the 4 weeks prior to randomization
• Received ≥ 4 doses of epoetin alfa during the 2 weeks prior to randomization
• Hemoglobin concentration ≤ 11.0 g/dL, per the most recent local laboratory value obtained during the 2 weeks prior to randomization
• Hemoglobin concentration ≤ 11.0 g/dL, at the screening visit, using the hemoglobin point of care device provided by Amgen
• Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the most recent local laboratory value obtained during the 4 weeks prior to randomization

You may not qualify if:

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to randomization
• Other investigational procedures while participating in this study are excluded
• Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
• Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
• Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy or biologics) within 5 years of randomization, with the exception of locally excised non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
• Subject is currently pregnant or planning to become pregnant during treatment and for 30 days after the end of treatment
• Subject is currently breast feeding or planning on breast feeding during treatment and for 30 days after the end of treatment
• Females of reproductive potential who are not willing to use an acceptable method of effective contraception during treatment and for at least 30 days after the end of treatment
• Currently receiving IV antibiotics
• Currently receiving systemic immunosuppressive therapy known to cause anemia, including treatment for active hepatitis (eg, azathioprine, mycophenolate mofetil, ≥ 10 mg prednisone \[or equivalent\]/day, interferon)
• Known human immunodeficiency virus (HIV) positive
• Known neutralizing anti-erythropoietic protein antibodies
• Known sensitivity to epoetin alfa
• Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, planned vacations where away from dialysis unit for more than 2 weeks) to the best of the subject and investigator's knowledge
• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Sponsors & Collaborators

• Amgen: lead

Study Sites (37)

Research Site

Cerritos, California, 90703, United States

Location

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Glendale, California, 91204, United States

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Los Angeles, California, 90022, United States

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Los Angeles, California, 90057, United States

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Montebello, California, 90640, United States

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Riverside, California, 92501, United States

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San Diego, California, 92115, United States

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Simi Valley, California, 93065, United States

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Vacaville, California, 95687, United States

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Whittier, California, 90606, United States

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Miami, Florida, 33150, United States

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Miami Gardens, Florida, 33169, United States

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Pembroke Pines, Florida, 33025, United States

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Macon, Georgia, 31217, United States

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Statesboro, Georgia, 30458, United States

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Merrillville, Indiana, 46410, United States

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Michigan City, Indiana, 46360, United States

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Detroit, Michigan, 48202, United States

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Pontiac, Michigan, 48341, United States

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Roseville, Michigan, 48066, United States

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Kansas City, Missouri, 64111, United States

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Lincoln, Nebraska, 68510, United States

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Astoria, New York, 11102, United States

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Brooklyn, New York, 11235, United States

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Rosedale, New York, 11422, United States

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The Bronx, New York, 10461, United States

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Carrboro, North Carolina, 27510, United States

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Wilmington, North Carolina, 28401, United States

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Meadville, Pennsylvania, 16335, United States

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Philadelphia, Pennsylvania, 19106, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77070, United States

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San Antonio, Texas, 78229, United States

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Burlington, Vermont, 05401, United States

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Hampton, Virginia, 23666, United States

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Norfolk, Virginia, 23502, United States

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Toa Baja, 00949, Puerto Rico

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

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; Hematologic Diseases; Hemic and Lymphatic Diseases

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: October 1, 2014
• Study Start: April 1, 2015
• Primary Completion: April 27, 2016
• Study Completion: May 25, 2016
• Last Updated: May 19, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-05

Locations

PR (1); US (36)