Clinical trial NCT02253654: Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Official title: A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Insufficiency, Chronic
Anemia
Renal Dialysis
Erythrocyte Transfusion
Keywords: Chronic Kidney Disease
Anemia
Hemodialysis
Red Blood Cell Transfusion
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
timeFrame: The evaluation period (weeks 13-37)
Secondary outcomes:
measure: Hemoglobin Concentration at Each Visit
timeFrame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
measure: Percentage of Participants With Transfusion Events Overall and During Each Study Period
timeFrame: 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
measure: Hemoglobin Rate of Change at Each Visit
timeFrame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
measure: Hemoglobin Intra-subject Variability
timeFrame: The evaluation period (weeks 13 to 37)
measure: Percentage of Participants With Hemoglobin Excursions at Each Visit
timeFrame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
measure: Weekly Epoetin Alfa Dose at Each Visit
timeFrame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
measure: Number of RBC Units Transfused Overall and During Each Study Period
timeFrame: 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
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Research Site
state: California
city: Glendale
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Montebello
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Simi Valley
country: United States
facility: Research Site
state: California
city: Vacaville
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Miami Gardens
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Statesboro
country: United States
facility: Research Site
state: Georgia
city: Merrillville
country: United States
facility: Research Site
state: Indiana
city: Michigan City
country: United States
facility: Research Site
state: Indiana
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Pontiac
country: United States
facility: Research Site
state: Michigan
city: Roseville
country: United States
facility: Research Site
state: Michigan
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Astoria
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Rosedale
country: United States
facility: Research Site
state: New York
city: The Bronx
country: United States
facility: Research Site
state: New York
city: Carrboro
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Meadville
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Hampton
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Toa Baja
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: