Clinical trial NCT02780726: A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
Keywords: Peritoneal dialysis
Roxadustat
Renal anemia
ASP1517
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: FibroGen
First posted: 2016-05-23
Enrollment: 56
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 peritoneal dialysis chronic kidney disease patients with anemia.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin (Hb) Response Rate from Week 18 to Week 24
timeFrame: Up to Week 24
Secondary outcomes:
measure: Hb Response rate
timeFrame: Up to Week 24
measure: Average Hb levels from week 18 to week 24
timeFrame: Up to week 24
measure: Change from baseline in the average Hb levels of week 18 to week 24
timeFrame: Baseline and up to Week 24
measure: Rate of rise in Hb levels (g/dL/week)
timeFrame: Up to Week 4
measure: Proportion of time points with target Hb levels
timeFrame: Up to Week 24
measure: Proportion of participants who achieve the target Hb level at each week
timeFrame: Up to Week 24
measure: Proportion of participants who achieve 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 level at each week
timeFrame: Baseline and Up to Week 24
measure: Efficacy assessed by hematocrit
timeFrame: Up to Week 24
measure: Efficacy assessed by reticulocytes/ erythrocytes
timeFrame: Up to Week 24
measure: Efficacy assessed by Iron (Fe)
timeFrame: Up to Week 24
measure: Efficacy assessed by ferritin
timeFrame: Up to Week 24
measure: Efficacy assessed by transferrin
timeFrame: Up to Week 24
measure: Efficacy assessed by total iron binding capacity
timeFrame: Up to Week 24
measure: Efficacy assessed by soluble transferrin receptor
timeFrame: Up to Week 24
measure: Efficacy assessed by transferrin saturation
timeFrame: Up to Week 24
measure: Efficacy assessed by reticulocyte hemoglobin content
timeFrame: Up to Week 24
measure: Quality of life assessed by SF-36
timeFrame: Up to Week 24
measure: Quality of life assessed by EQ-5D
timeFrame: Up to Week 24
measure: Quality of life assessed by FACT-An
timeFrame: Up to Week 24
measure: Occurrence 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 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: Number of participants with abnormal Laboratory values and/or adverse events related to treatment
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 JP00002
city: Aichi
country: Japan
facility: Site JP00004
city: Aichi
country: Japan
facility: Site JP00010
city: Aichi
country: Japan
facility: Site JP00013
city: Fukuoka
country: Japan
facility: Site JP00001
city: Fukuoka
country: Japan
facility: Site JP00005
city: Hokkaido
country: Japan
facility: Site JP00012
city: Hokkaido
country: Japan
facility: Site JP00014
city: Ishikawa
country: Japan
facility: Site JP00006
city: Kanagawa
country: Japan
facility: Site JP00008
city: Nagano
country: Japan
facility: Site JP00003
city: Okayama
country: Japan
facility: SIte JP00015
city: Osaka
country: Japan
facility: Site JP00009
city: Tokushima
country: Japan
facility: Site JP00007
city: Toyama
country: Japan
facility: Site JP00011
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.