ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia Clinical Trial
Official title:
A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
| Verified date | December 2019 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | December 12, 2017 |
| Est. primary completion date | December 12, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Mean of the subjects' two most recent Hb values during the Screening Period must be =10.0 g/dL with an absolute difference =1.0 g/dL between the two values - Either transferrin saturation (TSAT) = 5% or serum ferritin = 30 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 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 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 considered 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site JP00003 | Aichi | |
| Japan | Site JP00005 | Aichi | |
| Japan | Site JP00042 | Aichi | |
| Japan | Site JP00044 | Aichi | |
| Japan | Site JP00020 | Chiba | |
| Japan | Site JP00010 | Ehime | |
| Japan | Site JP00021 | Ehime | |
| Japan | Site JP00013 | Fukuoka | |
| Japan | Site JP00011 | Fukushima | |
| Japan | Site JP00035 | Fukushima | |
| Japan | Site JP00017 | Gifu | |
| Japan | Site JP00033 | Gifu | |
| Japan | Site JP00012 | Gunma | |
| Japan | Site JP00016 | Gunma | |
| Japan | Site JP00025 | Gunma | |
| Japan | Site JP00046 | Hiroshima | |
| Japan | Site JP00015 | Hokkaido | |
| Japan | Site JP00023 | Hokkaido | |
| Japan | Site JP00028 | Hokkaido | |
| Japan | Site JP00038 | Hokkaido | |
| Japan | Site JP00040 | Hokkaido | |
| Japan | Site JP00045 | Hokkaido | |
| Japan | Site JP00034 | Hyogo | |
| Japan | Site JP00008 | Ibaraki | |
| Japan | Site JP00018 | Ibaraki | |
| Japan | Site JP00027 | Ibaraki | |
| Japan | Site JP00030 | Ibaraki | |
| Japan | Site JP00022 | Ishikawa | |
| Japan | Site JP00041 | Kagoshima | |
| Japan | Site JP00031 | Kumamoto | |
| Japan | Site JP00037 | Kumamoto | |
| Japan | Site JP00009 | Nagano | |
| Japan | Site JP00014 | Nagano | |
| Japan | Site JP00026 | Nagano | |
| Japan | Site JP00047 | Nagano | |
| Japan | Site JP00002 | Niigata | |
| Japan | Site JP00029 | Niigata | |
| Japan | Site JP00039 | Okayama | |
| Japan | Site JP00024 | Okinawa | |
| Japan | Site JP00036 | Osaka | |
| Japan | Site JP00006 | Saitama | |
| Japan | Site JP00032 | Shizuoka | |
| Japan | Site JP00043 | Tokushima | |
| Japan | Site JP00048 | Tokyo | |
| Japan | Site JP00007 | Tottori | |
| Japan | Site JP00019 | Toyama | |
| Japan | Site JP00004 | Yamaguchi |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc | FibroGen |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hemoglobin (Hb) Response rate | Hb response is defined as reaching target values for Hb and change of Hb from baseline | Up to Week 24 | |
| Secondary | Average Hb level from Week 18 to 24 | Week 18 to 24 | ||
| Secondary | Change from baseline in the average Hb level from Week 18 to 24 | Baseline and Weeks 18 to 24 | ||
| Secondary | Proportion of participants with the target Hb level from Week 18 to 24 | Week 18 to 24 | ||
| Secondary | 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 | ||
| Secondary | Proportion of measurement points with the target Hb level | Up to Week 24 | ||
| Secondary | Proportion of participants with the target Hb level at each week | Up to Week 24 | ||
| Secondary | Proportion of participants with the lower limit of the target Hb level | Up to Week 24 | ||
| Secondary | Time to achieve the lower limit of the target Hb level | Up to Week 24 | ||
| Secondary | Change from baseline in Hb levels to each week | Baseline and Up to Week 24 | ||
| Secondary | Average hematocrit level | Up to Week 24 | ||
| Secondary | Average reticulocyte level | Up to Week 24 | ||
| Secondary | Average iron (Fe) level | Up to Week 24 | ||
| Secondary | Average ferritin level | Up to Week 24 | ||
| Secondary | Average transferrin level | Up to Week 24 | ||
| Secondary | Average total iron binding capacity level | Up to Week 24 | ||
| Secondary | Average soluble transferrin receptor level | Up to Week 24 | ||
| Secondary | Average transferrin saturation level | Up to Week 24 | ||
| Secondary | Average reticulocyte hemoglobin content level | Up to Week 24 | ||
| Secondary | Quality of life assessed by EQ-5D-5L | EQ-5D-5L: EuroQol 5 Dimension 5 Levels | Up to Week 24 | |
| Secondary | Quality of life assessed by FACT-An | FACT-An: Functional Assessment of Cancer Therapy-Anemia | Up to Week 24 | |
| Secondary | Number of hospitalizations | Up to Week 24 | ||
| Secondary | Duration of hospitalizations | Up to Week 24 | ||
| Secondary | Safety assessed by incidence of adverse events | Up to Week 24 | ||
| Secondary | Number of participants with abnormal Laboratory values and/or adverse events related to treatment | Up to Week 24 | ||
| Secondary | Number of participants with abnormal Vital signs and/or adverse events related to treatment | Up to Week 24 | ||
| Secondary | Safety assessed by standard 12-lead electrocardiogram | Up to Week 24 | ||
| Secondary | Plasma concentration of unchanged ASP1517 | Up to Week 24 |