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

Anemia Clinical Trial

Official title:

A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253654
• Other study ID #: 20110208
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2014
• Last updated: May 18, 2017
• Start date: April 1, 2015
• Est. completion date: May 25, 2016

Study information

• Verified date: May 2017
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 25, 2016
• Est. primary completion date: April 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Previously entered this study

• Occurrence of any of the following within 8 weeks prior to randomization:

• Seizure

• Clinically relevant active bleeding (eg, gastrointestinal bleed)

• RBC transfusion

• Any hospitalization or observational stay > 24 hours

• Uncontrolled hypertension, per the investigator within the 4 weeks prior to randomization

• Expected or scheduled solid organ transplant(eg, kidney) within 40 weeks after randomization

• Expected or scheduled to change dialysis modality (eg, peritoneal dialysis, home hemodialysis) within 40 weeks after randomization

Related Conditions & MeSH terms

• Anemia
• Erythrocyte Transfusion
• Kidney Diseases
• Renal Dialysis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Epoetin alfa
Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.

Locations

Country	Name	City	State
Puerto Rico	Research Site	Toa Baja
United States	Research Site	Astoria	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Burlington	Vermont
United States	Research Site	Carrboro	North Carolina
United States	Research Site	Cerritos	California
United States	Research Site	Detroit	Michigan
United States	Research Site	Glendale	California
United States	Research Site	Hampton	Virginia
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Macon	Georgia
United States	Research Site	Meadville	Pennsylvania
United States	Research Site	Merrillville	Indiana
United States	Research Site	Miami	Florida
United States	Research Site	Miami Gardens	Florida
United States	Research Site	Michigan City	Indiana
United States	Research Site	Montebello	California
United States	Research Site	Norfolk	Virginia
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pontiac	Michigan
United States	Research Site	Riverside	California
United States	Research Site	Rosedale	New York
United States	Research Site	Roseville	Michigan
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Simi Valley	California
United States	Research Site	Statesboro	Georgia
United States	Research Site	The Bronx	New York
United States	Research Site	Vacaville	California
United States	Research Site	Whittier	California
United States	Research Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of Participants With Transfusion Events Overall and During Each Study Period	The percentage of participants who received red blood cell (RBC) transfusions during the study 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
Secondary	Hemoglobin Rate of Change at Each Visit	Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.	Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Secondary	Hemoglobin Intra-subject Variability	Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.	The evaluation period (weeks 13 to 37)
Secondary	Percentage of Participants With Hemoglobin Excursions at Each Visit	An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.	Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Secondary	Weekly Epoetin Alfa Dose at Each Visit		Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Secondary	Number of RBC Units Transfused Overall and During Each Study Period	The number of red blood cell (RBC) units transfused during the study 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

External Links

•   AmgenTrials clinical trials website