Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia Clinical Trial
Official title:
A Phase 3, Multi-center, Open-label Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis 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 peritoneal dialysis chronic kidney disease patients with anemia.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | August 2, 2017 |
| Est. primary completion date | August 2, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - 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 - Subjects who have not received Erythropoieses Stimulating Agents (ESAs): - Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment - Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment. - 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 (TSAT) = 5% or serum ferritin = 30 ng/mL during the screening period - Subjects who have been receiving ESAs: - Subjects with renal anemia who have been receiving ESA within the doses approved in Japan for more than 8 weeks after starting peritoneal dialysis, before the screening assessment - Mean of the subject's two most recent Hb values before randomization during the Screening Period must be =10.0 g/dL and =12.0 g/dL - TSAT = 20% or serum ferritin = 100 ng/mL during the screening period Exclusion Criteria: - Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment - 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), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, 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 JP00002 | Aichi | |
| Japan | Site JP00004 | Aichi | |
| Japan | Site JP00010 | Aichi | |
| Japan | Site JP00013 | Aichi | |
| Japan | Site JP00001 | Fukuoka | |
| Japan | Site JP00005 | Fukuoka | |
| Japan | Site JP00012 | Hokkaido | |
| Japan | Site JP00014 | Hokkaido | |
| Japan | Site JP00006 | Ishikawa | |
| Japan | Site JP00008 | Kanagawa | |
| Japan | Site JP00003 | Nagano | |
| Japan | SIte JP00015 | Okayama | |
| Japan | Site JP00009 | Osaka | |
| Japan | Site JP00007 | Tokushima | |
| Japan | Site JP00011 | Toyama |
| 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 in this outcome | Up to Week 24 | |
| Secondary | Hb Response rate | Hb response is defined as reaching target values for Hb and change of Hb from baseline in this outcome. | Up to Week 24 | |
| Secondary | Average Hb levels from week 18 to week 24 | Up to week 24 | ||
| Secondary | Change from baseline in the average Hb levels of week 18 to week 24 | Baseline and up to Week 24 | ||
| Secondary | Rate of rise in Hb levels (g/dL/week) | Up to Week 4 | ||
| Secondary | Proportion of time points with target Hb levels | Up to Week 24 | ||
| Secondary | Proportion of participants who achieve the target Hb level at each week | Up to Week 24 | ||
| Secondary | Proportion of participants who achieve 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 level at each week | Baseline and Up to Week 24 | ||
| Secondary | Efficacy assessed by hematocrit | Hematocrit will be summarized by ASP1517 low dose Erythropoieses Stimulating Agent (ESA) untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by reticulocytes/ erythrocytes | Reticulocytes/Erythrocytes will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by Iron (Fe) | Fe will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by ferritin | Ferritin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by transferrin | Transferrin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by total iron binding capacity | Total iron binding capacity will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by soluble transferrin receptor | Soluble transferrin receptor will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by transferrin saturation | Transferrin saturation will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Efficacy assessed by reticulocyte hemoglobin content | Reticulocyte hemoglobin content will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group. | Up to Week 24 | |
| Secondary | Quality of life assessed by SF-36 | SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey | Up to Week 24 | |
| Secondary | Quality of life assessed by EQ-5D | EQ-5D: EuroQol 5 Dimension | 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 | Occurrence of hospitalizations | Up to Week 24 | ||
| Secondary | Safety assessed by incidence of adverse events | 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 | Number of participants with abnormal Laboratory values and/or adverse events related to treatment | Up to Week 24 | ||
| Secondary | Plasma concentration of unchanged ASP1517 | Up to Week 24 |