A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
- Conditions
- Hemodialysis Chronic Kidney Disease Patients With Anemia
- Interventions
- Registration Number
- NCT02952092
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
- Subjects with renal anemia who have been receiving recombinant human erythropoietin (rHuEPO, two times weekly or three times weekly) or darbepoetin alfa (intravenous treatment) within the doses approved in Japan for more than 8 weeks before the screening assessment
- Mean of the subject's two most recent Hb values before dialysis after the longest dialysis interval during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
- Either transferrin saturation (TSAT) ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period
- Female subject must either:
Be of non-childbearing potential:
-
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
-
documented surgically sterile Or, if of childbearing potential,
-
Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
-
And have a negative pregnancy test at Screening
-
And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
- Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration
- Concurrent retinal neovascular lesion untreated and macular edema untreated
- Concurrent autoimmune disease with inflammation that could impact erythropoiesis
- History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastroparesis
- Uncontrolled hypertension
- Concurrent congestive heart failure (NYHA Class III or higher)
- History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
- Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
- Concurrent other form of anemia than renal anemia
- History of pure red cell aplasia
- Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or total bilirubin that is greater than the criteria, or previous or concurrent another serious liver disease at screening assessment
- Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
- Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) and/or ophthalmological surgery within 4 weeks before the screening assessment
- Having undergone a kidney transplantation
- Having a previous history of treatment with ASP1517
- History of serious drug allergy including anaphylactic shock
- Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darbepoetin alfa Group Darbepoetin alfa Subjects will take the study drug once a week. ASP1517 Group roxadustat Subjects will take the study drug at two- or three-day intervals.
- Primary Outcome Measures
Name Time Method Change from baseline in the average hemoglobin (Hb) Baseline and Weeks 18 to 24
- Secondary Outcome Measures
Name Time Method Quality of life assessed by SF-36 Up to Week 24 SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey
Number of hospitalizations Up to Week 24 Number of participants with abnormal Vital signs and/or adverse events related to treatment Up to Week 24 Safety assessed by ophthalmological examination: fundoscopy Up to Week 24 Quality of life assessed by EQ-5D-5L Up to Week 24 EQ-5D-5L: EuroQol 5 Dimension 5-Levels
Proportion of participants with the target Hb level at each week Up to Week 24 Average Hb from Week 18 to Week 24 Week 18 to 24 Proportion of participants with the target Hb level from Week 18 to Week 24 Week 18 to 24 Change from week 0 in Hb levels to each week Up to Week 24 Average ferritin level Up to Week 24 Average transferrin level Up to Week 24 Average total iron binding capacity level Up to Week 24 Average soluble transferrin receptor level Up to Week 24 Proportion of measurement points with the target Hb level from Week 18 to Week 24 Week 18 to 24 Average hematocrit level Up to Week 24 Average reticulocyte level Up to Week 24 Average iron (Fe) level Up to Week 24 Average transferrin saturation level Up to Week 24 Average reticulocyte hemoglobin content level Up to Week 24 Quality of life assessed by FACT-An Up to Week 24 FACT-An: Functional Assessment of Cancer Therapy-Anemia
Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment Up to Week 4 Plasma concentration of unchanged ASP1517 Up to Week 24 Duration of hospitalizations Up to Week 24 Safety assessed by incidence of adverse events Up to Week 24 Number of participants with abnormal 12-lead electrocardiogram (ECG) values Up to Week 24 Any clinically significant adverse changes on the ECG will be reported as adverse events.
Number of participants with abnormal Laboratory values and/or adverse events related to treatment Up to Week 24 Safety assessed by ophthalmological examination: Optical coherence tomography Up to Week 24 Safety assessed by ophthalmological examination: visual acuity Up to Week 24
Trial Locations
- Locations (57)
Site JP00033
🇯🇵Aichi, Japan
Site JP00004
🇯🇵Ehime, Japan
Site JP00041
🇯🇵Ibaraki, Japan
Site JP00042
🇯🇵Ibaraki, Japan
Site JP00002
🇯🇵Nagano, Japan
Site JP00008
🇯🇵Aichi, Japan
Site JP00018
🇯🇵Aichi, Japan
Site JP00049
🇯🇵Fukuoka, Japan
Site JP00020
🇯🇵Aichi, Japan
Site JP00011
🇯🇵Gunma, Japan
Site JP00057
🇯🇵Fukushima, Japan
Site JP00003
🇯🇵Hokkaido, Japan
Site JP00037
🇯🇵Gunma, Japan
Site JP00047
🇯🇵Ibaraki, Japan
Site JP00013
🇯🇵Nagasaki, Japan
Site JP00053
🇯🇵Tokyo, Japan
Site JP00028
🇯🇵Kumamoto, Japan
Site JP00025
🇯🇵Yamaguchi, Japan
Site JP00032
🇯🇵Aichi, Japan
Site JP00040
🇯🇵Aichi, Japan
Site JP00055
🇯🇵Ehime, Japan
Site JP00009
🇯🇵Fukui, Japan
Site JP00059
🇯🇵Fukui, Japan
Site JP00014
🇯🇵Fukuoka, Japan
Site JP00010
🇯🇵Fukushima, Japan
Site JP00030
🇯🇵Gifu, Japan
Site JP00056
🇯🇵Fukushima, Japan
Site JP00031
🇯🇵Hokkaido, Japan
Site JP00038
🇯🇵Hokkaido, Japan
Site JP00048
🇯🇵Hokkaido, Japan
Site JP00045
🇯🇵Ibaraki, Japan
Site JP00046
🇯🇵Ibaraki, Japan
Site JP00029
🇯🇵Kumamoto, Japan
Site JP00044
🇯🇵Tokushima, Japan
Site JP00052
🇯🇵Tokyo, Japan
Site JP00021
🇯🇵Toyama, Japan
Site JP00022
🇯🇵Toyama, Japan
Site JP00039
🇯🇵Toyama, Japan
Site JP00024
🇯🇵Yamagata, Japan
Site JP00026
🇯🇵Gunma, Japan
Site JP00050
🇯🇵Gifu, Japan
Site JP00017
🇯🇵Ibaraki, Japan
Site JP00043
🇯🇵Kagoshima, Japan
Site JP00005
🇯🇵Kanagawa, Japan
Site JP00006
🇯🇵Kyoto, Japan
Site JP00012
🇯🇵Nagano, Japan
Site JP00051
🇯🇵Nagano, Japan
Site JP00027
🇯🇵Nagano, Japan
Site JP00034
🇯🇵Niigata, Japan
Site JP00036
🇯🇵Okayama, Japan
Site JP00001
🇯🇵Niigata, Japan
Site JP00007
🇯🇵Osaka, Japan
Site JP00015
🇯🇵Osaka, Japan
Site JP00035
🇯🇵Saitama, Japan
Site JP00058
🇯🇵Ibaraki, Japan
Site JP00054
🇯🇵Ibaraki, Japan
Site JP00016
🇯🇵Saitama, Japan