A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia

Chronic Kidney Disease Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, 2-Arm, Open-label Study of Intermittent Oral Dosing of ASP1517 for the Treatment of Anemia in Erythropoiesis Stimulating Agent-untreated Chronic Kidney Disease Patients Not on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964936
• Other study ID #: 1517-CL-0314
• Status: Completed
• Phase: Phase 3
• Start date: January 11, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: April 2021
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects who were diagnosed with non-dialysis chronic kidney disease (CKD) and who are considered not to require renal replacement therapy during the study period

• 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 = 5% or serum ferritin = 30 ng/mL

• Female subject must either:

Be of non-childbearing potential:

• post-menopausal prior to pre-screening, or

• documented surgically sterile Or, if of childbearing potential,

• Agree not to try to become pregnant during the study after informed consent acquisition and for 28 days after the final study drug administration

• And have a negative urine pregnancy test at pre-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 pre-screening and throughout the study period and for 28 days after the final study drug administration.

• Female subject must agree not to breastfeed starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.

• Female subject must not donate ova starting at pre-screening and throughout the study period, and 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 pre-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 pre-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 pre-screening assessment

• Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the pre-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 ESA, protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the pre-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 pre-screening assessment

• Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)

• Having undergone red blood transfusion and/or a surgical procedure considered to promote anemia within 4 weeks before the pre-screening assessment

• Having undergone a kidney transplantation

• History of serious drug allergy including anaphylactic shock

• Having a previous history of treatment with ASP1517

• Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• roxadustat
Oral administration

Locations

Country	Name	City	State
Japan	Site JP00007	Aichi
Japan	Site JP00018	Aichi
Japan	Site JP00028	Aichi
Japan	Site JP00001	Chiba
Japan	Site JP00035	Ehime
Japan	Site JP00012	Fukui
Japan	Site JP00011	Fukuoka
Japan	Site JP00031	Fukuoka
Japan	Site JP00030	Hiroshima
Japan	Site JP00034	Hiroshima
Japan	Site JP00036	Hiroshima
Japan	Site JP00005	Hokkaido
Japan	Site JP00020	Hyogo
Japan	Site JP00015	Ibaraki
Japan	Site JP00017	Ibaraki
Japan	Site JP00021	Ibaraki
Japan	Site JP00025	Ibaraki
Japan	Site JP00037	Ibaraki
Japan	Site JP00033	Ishikawa
Japan	Site JP00029	Iwate
Japan	Site JP00006	Kanagawa
Japan	Site JP00014	Kanagawa
Japan	Site JP00038	Kanagawa
Japan	Site JP00010	Miyagi
Japan	Site JP00016	Nagano
Japan	Site JP00024	Niigata
Japan	Site JP00032	Oita
Japan	Site JP00003	Osaka
Japan	Site JP00009	Osaka
Japan	Site JP00026	Osaka
Japan	Site JP00002	Saitama
Japan	Site JP00019	Saitama
Japan	Site JP00027	Saitama
Japan	Site JP00004	Tokyo
Japan	Site JP00013	Tokyo
Japan	Site JP00022	Tokyo
Japan	Site JP00023	Tokyo
Japan	Site JP00008	Toyama

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	FibroGen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin (Hb) response rate	Hb response is defined as reaching target values for Hb.	Baseline and week 24
Secondary	Change from baseline in the average Hb from Week 18 to Week 24		Baseline and Weeks 18 to 24
Secondary	Proportion of participants who achieve the target Hb level at the average of Week 18 to 24	Hb response defined as average Hb within the target range in this outcome	Weeks 18 to 24
Secondary	Rate of rise in Hb levels (g/dL/week) from week 0 at the earliest date of week 4, time to discontinuation, or time of dose adjustment		Up to Week 4
Secondary	Proportion of measurement points with the target Hb level		Weeks 18 to 24
Secondary	Proportion of participants who achieves the target Hb level at each week		Up to Week 24
Secondary	Proportion of participants who achieves 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 to each week		Baseline and Up to Week 24
Secondary	Quality of life assessed by EQ-5D-5L	EQ-5D: EuroQol 5 Dimension 5 Levels	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	Number of participants with abnormal Vital signs and/or adverse events related to treatment		Up to Week 24
Secondary	Safety assessed by body weight		Up to Week 24
Secondary	Safety assessed by incidence of adverse events		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
Secondary	Average hematocrit level		Up to Week 24
Secondary	Average reticulocyte level		Up to Week 24
Secondary	Average iron (Fe) level		Up to Week 24
Secondary	Average ferritin level		Up to Week 24
Secondary	Average transferrin level		Up to Week 24
Secondary	Average total iron binding capacity level		Up to Week 24
Secondary	Average soluble transferrin receptor level		Up to Week 24
Secondary	Average transferrin saturation level		Up to Week 24
Secondary	Average reticulocyte hemoglobin content level		Up to Week 24
Secondary	Number of hospitalizations		Up to Week 24
Secondary	Duration of hospitalizations		Up to Week 24