A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Overview
- Phase
- Phase 4
- Intervention
- Epoetin alfa
- Conditions
- Renal Insufficiency, Chronic
- Sponsor
- Amgen
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
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)
Arms & Interventions
Epoetin alfa Alternative Titration
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
Epoetin alfa USPI Titration
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
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)