Clinical trial NCT02779764: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis Patients With Renal Anemia
Keywords: Hemodialysis
ASP1517
Roxadustat
Renal anemia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: FibroGen
First posted: 2016-05-20
Enrollment: 164
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin (Hb) Response Rate from Week 18 to Week 24
timeFrame: Week 18 to 24
Secondary outcomes:
measure: Hb Response Rate from Week 46 to Week 52
timeFrame: Week 46 to 52
measure: Average Hb from Week 18 to Week 24
timeFrame: Week 18 to Week 24
measure: Average Hb from Week 46 to Week 52
timeFrame: Week 46 to Week 52
measure: Change from baseline in the average Hb from Week 18 to Week 24
timeFrame: Baseline and Weeks 18 to 24
measure: Change from baseline in the average Hb from Week 46 to Week 52
timeFrame: Baseline and Weeks 46 to 52
measure: Proportion of participants with Hb values within the target value in each post-dosing time point
timeFrame: Up to Week 52
measure: Change from baseline in Hb to each post-dosing time point
timeFrame: Baseline and Up to Week 52
measure: Proportion of measurement points with target Hb level from Week 18 to Week 24
timeFrame: Week 18 to Week 24
measure: Proportion of measurement points with target Hb level from Week 46 to Week 52
timeFrame: Week 46 to Week 52
measure: 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
timeFrame: Up to Week 4
measure: Average hematocrit level
timeFrame: Up to Week 52
measure: Average reticulocyte level
timeFrame: Up to Week 52
measure: Average Fe level
timeFrame: Up to Week 52
measure: Average ferritin level
timeFrame: Up to Week 52
measure: Average transferrin level
timeFrame: Up to Week 52
measure: Average total iron binding capacity level
timeFrame: Up to Week 52
measure: Average soluble transferrin receptor level
timeFrame: Up to Week 52
measure: Average transferrin saturation level
timeFrame: Up to Week 52
measure: Average reticulocyte hemoglobin content level
timeFrame: Up to Week 52
measure: Quality of life assessed by SF-36
timeFrame: Up to Week 52
measure: Quality of life assessed by EQ-5D
timeFrame: Up to Week 52
measure: Quality of life assessed by FACT-An
timeFrame: Up to Week 52
measure: Number of hospitalizations
timeFrame: Up to Week 52
measure: Safety assessed by incidence of adverse events
timeFrame: Up to Week 52
measure: Number of participants with abnormal Vital signs and/or adverse events related to treatment
timeFrame: Up to Week 52
measure: Safety assessed by standard 12-lead electrocardiogram
timeFrame: Up to Week 52
measure: Number of participants with abnormal Laboratory values and/or adverse events related to treatment
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00017
city: Fukuoka
country: Japan
facility: Site JP00005
city: Gunma
country: Japan
facility: Site JP00004
city: Gunma
country: Japan
facility: Site JP00006
city: Hokkaido
country: Japan
facility: Site JP00018
city: Hokkaido
country: Japan
facility: Site JP00019
city: Hokkaido
country: Japan
facility: Site JP00021
city: Hyogo
country: Japan
facility: Site JP00023
city: Ibaraki
country: Japan
facility: Site JP00008
city: Ishikawa
country: Japan
facility: Site JP00020
city: Kumamoto
country: Japan
facility: Site JP00010
city: Kumamoto
country: Japan
facility: Site JP00022
city: Kumamoto
country: Japan
facility: Site JP00024
city: Kyoto
country: Japan
facility: Site JP00016
city: Nagano
country: Japan
facility: Site JP00002
city: Nagano
country: Japan
facility: Site JP00012
city: Nagano
country: Japan
facility: Site JP00015
city: Niigata
country: Japan
facility: Site JP00003
city: Osaka
country: Japan
facility: Site JP00025
city: Saitama
country: Japan
facility: Site JP00007
city: Shizuoka
country: Japan
facility: Site JP00009
city: Tokyo
country: Japan
facility: Site JP00014
city: Tottori
country: Japan
facility: Site JP00013
city: Wakayama
country: Japan
facility: Site JP00011
city: Yamaguchi
country: Japan
facility: Site JP00001
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: