Hemodialysis Patients With Renal Anemia Clinical Trial
Official title:
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
| 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 efficacy and safety of ASP1517 in hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating Agent formulation.
| Status | Completed |
| Enrollment | 164 |
| Est. completion date | November 28, 2017 |
| Est. primary completion date | May 16, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site JP00017 | Aichi | |
| Japan | Site JP00005 | Fukuoka | |
| Japan | Site JP00004 | Gunma | |
| Japan | Site JP00006 | Gunma | |
| Japan | Site JP00018 | Hokkaido | |
| Japan | Site JP00019 | Hokkaido | |
| Japan | Site JP00021 | Hokkaido | |
| Japan | Site JP00023 | Hyogo | |
| Japan | Site JP00008 | Ibaraki | |
| Japan | Site JP00020 | Ishikawa | |
| Japan | Site JP00010 | Kumamoto | |
| Japan | Site JP00022 | Kumamoto | |
| Japan | Site JP00024 | Kumamoto | |
| Japan | Site JP00016 | Kyoto | |
| Japan | Site JP00002 | Nagano | |
| Japan | Site JP00012 | Nagano | |
| Japan | Site JP00015 | Nagano | |
| Japan | Site JP00003 | Niigata | |
| Japan | Site JP00025 | Osaka | |
| Japan | Site JP00007 | Saitama | |
| Japan | Site JP00009 | Shizuoka | |
| Japan | Site JP00014 | Tokyo | |
| Japan | Site JP00013 | Tottori | |
| Japan | Site JP00011 | Wakayama | |
| Japan | Site JP00001 | Yamaguchi |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc | FibroGen |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Hb Response Rate from Week 46 to Week 52 | Week 46 to 52 | ||
| Secondary | Average Hb from Week 18 to Week 24 | Week 18 to Week 24 | ||
| Secondary | Average Hb from Week 46 to Week 52 | Week 46 to Week 52 | ||
| Secondary | Change from baseline in the average Hb from Week 18 to Week 24 | Baseline and Weeks 18 to 24 | ||
| Secondary | Change from baseline in the average Hb from Week 46 to Week 52 | Baseline and Weeks 46 to 52 | ||
| Secondary | Proportion of participants with Hb values within the target value in each post-dosing time point | Up to Week 52 | ||
| Secondary | Change from baseline in Hb to each post-dosing time point | Baseline and Up to Week 52 | ||
| Secondary | Proportion of measurement points with target Hb level from Week 18 to Week 24 | Week 18 to Week 24 | ||
| Secondary | Proportion of measurement points with target Hb level from Week 46 to Week 52 | Week 46 to Week 52 | ||
| 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 | Average hematocrit level | Up to Week 52 | ||
| Secondary | Average reticulocyte level | Up to Week 52 | ||
| Secondary | Average Fe level | Up to Week 52 | ||
| Secondary | Average ferritin level | Up to Week 52 | ||
| Secondary | Average transferrin level | Up to Week 52 | ||
| Secondary | Average total iron binding capacity level | Up to Week 52 | ||
| Secondary | Average soluble transferrin receptor level | Up to Week 52 | ||
| Secondary | Average transferrin saturation level | Up to Week 52 | ||
| Secondary | Average reticulocyte hemoglobin content level | Up to Week 52 | ||
| Secondary | Quality of life assessed by SF-36 | SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey | Up to Week 52 | |
| Secondary | Quality of life assessed by EQ-5D | EQ-5D: EuroQol 5 Dimension | Up to Week 52 | |
| Secondary | Quality of life assessed by FACT-An | FACT-An: Functional Assessment of Cancer Therapy-Anemia | Up to Week 52 | |
| Secondary | Number of hospitalizations | Up to Week 52 | ||
| Secondary | Safety assessed by incidence of adverse events | Up to Week 52 | ||
| Secondary | 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 | |
| Secondary | Safety assessed by standard 12-lead electrocardiogram | Up to Week 52 | ||
| Secondary | Number of participants with abnormal Laboratory values and/or adverse events related to treatment | Up to Week 52 |