Clinical trial NCT02780141: A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidney Disease Patients With Anemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
Keywords: Renal anemia
Roxadustat
ASP1517
Hemodialysis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: FibroGen
First posted: 2016-05-23
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin (Hb) Response rate
timeFrame: Up to Week 24
Secondary outcomes:
measure: Average Hb level from Week 18 to 24
timeFrame: Week 18 to 24
measure: Change from baseline in the average Hb level from Week 18 to 24
timeFrame: Baseline and Weeks 18 to 24
measure: Proportion of participants with the target Hb level from Week 18 to 24
timeFrame: Week 18 to 24
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: Proportion of measurement points with the target Hb level
timeFrame: Up to Week 24
measure: Proportion of participants with the target Hb level at each week
timeFrame: Up to Week 24
measure: Proportion of participants with the lower limit of the target Hb level
timeFrame: Up to Week 24
measure: Time to achieve the lower limit of the target Hb level
timeFrame: Up to Week 24
measure: Change from baseline in Hb levels to each week
timeFrame: Baseline and Up to Week 24
measure: Average hematocrit level
timeFrame: Up to Week 24
measure: Average reticulocyte level
timeFrame: Up to Week 24
measure: Average iron (Fe) level
timeFrame: Up to Week 24
measure: Average ferritin level
timeFrame: Up to Week 24
measure: Average transferrin level
timeFrame: Up to Week 24
measure: Average total iron binding capacity level
timeFrame: Up to Week 24
measure: Average soluble transferrin receptor level
timeFrame: Up to Week 24
measure: Average transferrin saturation level
timeFrame: Up to Week 24
measure: Average reticulocyte hemoglobin content level
timeFrame: Up to Week 24
measure: Quality of life assessed by EQ-5D-5L
timeFrame: Up to Week 24
measure: Quality of life assessed by FACT-An
timeFrame: Up to Week 24
measure: Number of hospitalizations
timeFrame: Up to Week 24
measure: Duration of hospitalizations
timeFrame: Up to Week 24
measure: Safety assessed by incidence of adverse events
timeFrame: Up to Week 24
measure: Number of participants with abnormal Laboratory values and/or adverse events related to treatment
timeFrame: Up to Week 24
measure: Number of participants with abnormal Vital signs and/or adverse events related to treatment
timeFrame: Up to Week 24
measure: Safety assessed by standard 12-lead electrocardiogram
timeFrame: Up to Week 24
measure: Plasma concentration of unchanged ASP1517
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00003
city: Aichi
country: Japan
facility: Site JP00005
city: Aichi
country: Japan
facility: Site JP00042
city: Aichi
country: Japan
facility: Site JP00044
city: Chiba
country: Japan
facility: Site JP00020
city: Ehime
country: Japan
facility: Site JP00010
city: Ehime
country: Japan
facility: Site JP00021
city: Fukuoka
country: Japan
facility: Site JP00013
city: Fukushima
country: Japan
facility: Site JP00011
city: Fukushima
country: Japan
facility: Site JP00035
city: Gifu
country: Japan
facility: Site JP00017
city: Gifu
country: Japan
facility: Site JP00033
city: Gunma
country: Japan
facility: Site JP00012
city: Gunma
country: Japan
facility: Site JP00016
city: Gunma
country: Japan
facility: Site JP00025
city: Hiroshima
country: Japan
facility: Site JP00046
city: Hokkaido
country: Japan
facility: Site JP00015
city: Hokkaido
country: Japan
facility: Site JP00023
city: Hokkaido
country: Japan
facility: Site JP00028
city: Hokkaido
country: Japan
facility: Site JP00038
city: Hokkaido
country: Japan
facility: Site JP00040
city: Hokkaido
country: Japan
facility: Site JP00045
city: Hyogo
country: Japan
facility: Site JP00034
city: Ibaraki
country: Japan
facility: Site JP00008
city: Ibaraki
country: Japan
facility: Site JP00018
city: Ibaraki
country: Japan
facility: Site JP00027
city: Ibaraki
country: Japan
facility: Site JP00030
city: Ishikawa
country: Japan
facility: Site JP00022
city: Kagoshima
country: Japan
facility: Site JP00041
city: Kumamoto
country: Japan
facility: Site JP00031
city: Kumamoto
country: Japan
facility: Site JP00037
city: Nagano
country: Japan
facility: Site JP00009
city: Nagano
country: Japan
facility: Site JP00014
city: Nagano
country: Japan
facility: Site JP00026
city: Nagano
country: Japan
facility: Site JP00047
city: Niigata
country: Japan
facility: Site JP00002
city: Niigata
country: Japan
facility: Site JP00029
city: Okayama
country: Japan
facility: Site JP00039
city: Okinawa
country: Japan
facility: Site JP00024
city: Osaka
country: Japan
facility: Site JP00036
city: Saitama
country: Japan
facility: Site JP00006
city: Shizuoka
country: Japan
facility: Site JP00032
city: Tokushima
country: Japan
facility: Site JP00043
city: Tokyo
country: Japan
facility: Site JP00048
city: Tottori
country: Japan
facility: Site JP00007
city: Toyama
country: Japan
facility: Site JP00019
city: Yamaguchi
country: Japan
facility: Site JP00004
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.