NCT02253654CompletedPhase 4
A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
Arms & Interventions
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.
Intervention: Epoetin alfa (Drug)
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.
Intervention: Epoetin alfa (Drug)
Outcomes
Primary Outcomes
Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
Time Frame: The evaluation period (weeks 13-37)
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.
Secondary Outcomes
- 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 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)
- Number of RBC Units Transfused 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)
- 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)
- 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)
Investigators
Study Sites (1)
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