A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoieses Stimulating Agent (ESA) Treatment
- Registration Number
- NCT02779764
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to evaluate the efficacy and safety of ASP1517 in hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating Agent formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- Subjects with renal anemia who have been receiving ESA (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 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 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 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 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 gastro-paresis
- 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
- 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 consider to promote anemia (excluding shunt reconstruction surgery for access to the blood) 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASP1517 Group roxadustat Study drug will be dosed three times weekly and dose adjustments will be made during the study.
- Primary Outcome Measures
Name Time Method Hemoglobin (Hb) Response Rate from Week 18 to Week 24 Week 18 to 24 Hb response defined as average Hb within the target range
- Secondary Outcome Measures
Name Time Method Hb Response Rate from Week 46 to Week 52 Week 46 to 52 Proportion of measurement points with target Hb level from Week 46 to Week 52 Week 46 to Week 52 Average Hb from Week 18 to Week 24 Week 18 to Week 24 Average Hb from Week 46 to Week 52 Week 46 to Week 52 Change from baseline in the average Hb from Week 18 to Week 24 Baseline and Weeks 18 to 24 Change from baseline in the average Hb from Week 46 to Week 52 Baseline and Weeks 46 to 52 Proportion of participants with Hb values within the target value in each post-dosing time point Up to Week 52 Change from baseline in Hb to each post-dosing time point Baseline and Up to Week 52 Proportion of measurement points with target Hb level from Week 18 to Week 24 Week 18 to Week 24 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 Average hematocrit level Up to Week 52 Average reticulocyte level Up to Week 52 Average Fe level Up to Week 52 Average ferritin level Up to Week 52 Average transferrin level Up to Week 52 Average total iron binding capacity level Up to Week 52 Average soluble transferrin receptor level Up to Week 52 Average transferrin saturation level Up to Week 52 Average reticulocyte hemoglobin content level Up to Week 52 Quality of life assessed by SF-36 Up to Week 52 SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey
Quality of life assessed by EQ-5D Up to Week 52 EQ-5D: EuroQol 5 Dimension
Quality of life assessed by FACT-An Up to Week 52 FACT-An: Functional Assessment of Cancer Therapy-Anemia
Number of hospitalizations Up to Week 52 Safety assessed by incidence of adverse events Up to Week 52 Number of participants with abnormal Vital signs and/or adverse events related to treatment Up to Week 52 Vital signs: blood pressure and pulse rate
Safety assessed by standard 12-lead electrocardiogram Up to Week 52 Number of participants with abnormal Laboratory values and/or adverse events related to treatment Up to Week 52
Trial Locations
- Locations (25)
Site JP00001
🇯🇵Yamaguchi, Japan
Site JP00004
🇯🇵Gunma, Japan
Site JP00021
🇯🇵Hokkaido, Japan
Site JP00023
🇯🇵Hyogo, Japan
Site JP00024
🇯🇵Kumamoto, Japan
Site JP00003
🇯🇵Niigata, Japan
Site JP00020
🇯🇵Ishikawa, Japan
Site JP00015
🇯🇵Nagano, Japan
Site JP00025
🇯🇵Osaka, Japan
Site JP00009
🇯🇵Shizuoka, Japan
Site JP00010
🇯🇵Kumamoto, Japan
Site JP00013
🇯🇵Tottori, Japan
Site JP00002
🇯🇵Nagano, Japan
Site JP00011
🇯🇵Wakayama, Japan
Site JP00019
🇯🇵Hokkaido, Japan
Site JP00006
🇯🇵Gunma, Japan
Site JP00005
🇯🇵Fukuoka, Japan
Site JP00017
🇯🇵Aichi, Japan
Site JP00018
🇯🇵Hokkaido, Japan
Site JP00008
🇯🇵Ibaraki, Japan
Site JP00022
🇯🇵Kumamoto, Japan
Site JP00016
🇯🇵Kyoto, Japan
Site JP00014
🇯🇵Tokyo, Japan
Site JP00012
🇯🇵Nagano, Japan
Site JP00007
🇯🇵Saitama, Japan