A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
- Registration Number
- NCT02964936
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Subjects who were diagnosed with non-dialysis chronic kidney disease (CKD) and who are considered not to require renal replacement therapy during the study period
- Mean of the subject's two most recent Hb values before randomization during the Screening Period must be <10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
- Either transferrin saturation ≥ 5% or serum ferritin ≥ 30 ng/mL
- Female subject must either:
Be of non-childbearing potential:
- post-menopausal prior to pre-screening, or
- documented surgically sterile Or, if of childbearing potential,
- Agree not to try to become pregnant during the study after informed consent acquisition and for 28 days after the final study drug administration
- And have a negative urine pregnancy test at pre-screening
- And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at pre-screening and throughout the study period and for 28 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
- Female subject must not donate ova starting at pre-screening and throughout the study period, and 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 birth control (at least one of which must be a barrier method) starting at pre-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 pre-screening and throughout the study period, and for 12 weeks after the final study drug administration
Exclusion Criteria
- Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
- 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 pre-screening assessment
- Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the pre-screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
- Concurrent other form of anemia than renal anemia
- Having received treatment with ESA, protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the pre-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 pre-screening assessment
- Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
- Having undergone red blood transfusion and/or a surgical procedure considered to promote anemia within 4 weeks before the pre-screening assessment
- Having undergone a kidney transplantation
- History of serious drug allergy including anaphylactic shock
- Having a previous history of treatment with ASP1517
- 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 ASP1517 Low dose group roxadustat Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study. ASP1517 High dose group roxadustat Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
- Primary Outcome Measures
Name Time Method Change from baseline in hemoglobin (Hb) response rate Baseline and week 24 Hb response is defined as reaching target values for Hb.
- Secondary Outcome Measures
Name Time Method Change from baseline in the average Hb from Week 18 to Week 24 Baseline and Weeks 18 to 24 Proportion of participants who achieve the target Hb level at the average of Week 18 to 24 Weeks 18 to 24 Hb response defined as average Hb within the target range in this outcome
Rate of rise in Hb levels (g/dL/week) from week 0 at the earliest date of week 4, time to discontinuation, or time of dose adjustment Up to Week 4 Proportion of measurement points with the target Hb level Weeks 18 to 24 Proportion of participants who achieves the target Hb level at each week Up to Week 24 Quality of life assessed by FACT-An Up to Week 24 FACT-An: Functional Assessment of Cancer Therapy-Anemia
Proportion of participants who achieves the lower limit of the target Hb level Up to Week 24 Time to achieve the lower limit of the target Hb level Up to Week 24 Change from baseline in Hb level to each week Baseline and Up to Week 24 Safety assessed by body weight Up to Week 24 Safety assessed by incidence of adverse events Up to Week 24 Number of participants with abnormal Laboratory values and/or adverse events related to treatment Up to Week 24 Quality of life assessed by EQ-5D-5L Up to Week 24 EQ-5D: EuroQol 5 Dimension 5 Levels
Safety assessed by standard 12-lead electrocardiogram Up to Week 24 Number of participants with abnormal Vital signs and/or adverse events related to treatment Up to Week 24 Plasma concentration of unchanged ASP1517 Up to Week 24 Average hematocrit level Up to Week 24 Average reticulocyte level Up to Week 24 Average iron (Fe) level 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 Average transferrin saturation level Up to Week 24 Average reticulocyte hemoglobin content level Up to Week 24 Number of hospitalizations Up to Week 24 Duration of hospitalizations Up to Week 24
Trial Locations
- Locations (38)
Site JP00029
🇯🇵Iwate, Japan
Site JP00032
🇯🇵Oita, Japan
Site JP00019
🇯🇵Saitama, Japan
Site JP00017
🇯🇵Ibaraki, Japan
Site JP00021
🇯🇵Ibaraki, Japan
Site JP00027
🇯🇵Saitama, Japan
Site JP00007
🇯🇵Aichi, Japan
Site JP00035
🇯🇵Ehime, Japan
Site JP00020
🇯🇵Hyogo, Japan
Site JP00006
🇯🇵Kanagawa, Japan
Site JP00038
🇯🇵Kanagawa, Japan
Site JP00013
🇯🇵Tokyo, Japan
Site JP00002
🇯🇵Saitama, Japan
Site JP00012
🇯🇵Fukui, Japan
Site JP00031
🇯🇵Fukuoka, Japan
Site JP00011
🇯🇵Fukuoka, Japan
Site JP00030
🇯🇵Hiroshima, Japan
Site JP00015
🇯🇵Ibaraki, Japan
Site JP00014
🇯🇵Kanagawa, Japan
Site JP00010
🇯🇵Miyagi, Japan
Site JP00037
🇯🇵Ibaraki, Japan
Site JP00016
🇯🇵Nagano, Japan
Site JP00023
🇯🇵Tokyo, Japan
Site JP00005
🇯🇵Hokkaido, Japan
Site JP00001
🇯🇵Chiba, Japan
Site JP00018
🇯🇵Aichi, Japan
Site JP00028
🇯🇵Aichi, Japan
Site JP00036
🇯🇵Hiroshima, Japan
Site JP00034
🇯🇵Hiroshima, Japan
Site JP00025
🇯🇵Ibaraki, Japan
Site JP00033
🇯🇵Ishikawa, Japan
Site JP00024
🇯🇵Niigata, Japan
Site JP00026
🇯🇵Osaka, Japan
Site JP00009
🇯🇵Osaka, Japan
Site JP00003
🇯🇵Osaka, Japan
Site JP00004
🇯🇵Tokyo, Japan
Site JP00022
🇯🇵Tokyo, Japan
Site JP00008
🇯🇵Toyama, Japan