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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Long-term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoiesis Stimulating Agent Treatment

Conditions
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Hemodialysis Patients With Renal Anemia

Intervention / Treatment
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* Drug: roxadustat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1517 Group<br>Study drug will be dosed three times weekly and dose adjustments will be made during the study. | Drug: roxadustat<br>* Oral<br>* Other names: ASP1517;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) Response Rate from Week 18 to Week 24 | Hb response defined as average Hb within the target range | Week 18 to 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb Response Rate from Week 46 to Week 52 |  | Week 46 to 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 | 
| Proportion of measurement points with target Hb level from Week 46 to Week 52 |  | Week 46 to Week 52 | 
| 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 | SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey | Up to Week 52 | 
| Quality of life assessed by EQ-5D | EQ-5D: EuroQol 5 Dimension | Up to Week 52 | 
| Quality of life assessed by FACT-An | FACT-An: Functional Assessment of Cancer Therapy-Anemia | Up to Week 52 | 
| 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 | Vital signs: blood pressure and pulse rate | Up to Week 52 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, ASP1517, Roxadustat, Renal anemia