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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02988973
Other study ID # 1517-CL-0310
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 12, 2017
Est. completion date March 26, 2020

Study information

Verified date September 2022
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term treatment of ASP1517 (52 weeks).


Description:

This study consists of the following three cohorts. Cohort 1; subjects converted from rHuEPO or DA to ASP1517, Cohort 2; subjects converted from rHuEPO or DA to DA, Cohort 3; subjects converted from epoetin beta pegol (CERA) to ASP1517. In Cohort 1 and 3, ASP1517 will be administered orally for 52 weeks. In Cohort 2, DA will be administered subcutaneously for 24 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 334
Est. completion date March 26, 2020
Est. primary completion date September 13, 2019
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 and who are considered not to require renal replacement therapy during the study period - Subjects with renal anemia who have been receiving erythropoiesis stimulating agent (ESA) by subcutaneous injection and whose Hb values are considered stable. - 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 - Either transferrin saturation = 20% or serum ferritin = 100 ng/mL - Female subject must either: Be of non-childbearing potential: - post-menopausal, 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 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 continued 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 continued 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 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 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 untreated or macular edema untreated, and patients with any condition that significantly compromises the ability to visualize the retina - 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 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 - History of pure red cell aplasia - Having received treatment with 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 consider to promote anemia and/or ophthalmological surgery 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 or participation in this study - Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition

Study Design


Intervention

Drug:
roxadustat
Oral administration
DA
Subcutaneous administration

Locations

Country Name City State
Japan Site JP00049 Aasahikawa Hokkaido
Japan Site JP00025 Adachi-ku Tokyo
Japan Site JP00029 Ageo Saitama
Japan Site JP00022 Amagasaki Hyogo
Japan Site JP00043 Bunkyo-ku Tokyo
Japan Site JP00063 Chiyoda-ku Tokyo
Japan Site JP00047 Fujisawa Kanagawa
Japan Site JP00014 Fukui
Japan Site JP00033 Fukuoka
Japan Site JP00065 Fukuoka
Japan Site JP00037 Hatsukaichi Hiroshima
Japan Site JP00059 Higashiosaka Osaka
Japan Site JP00067 Hino Tokyo
Japan Site JP00032 Hiroshima
Japan Site JP00039 Hiroshima
Japan Site JP00052 Hitachi Ibaraki
Japan Site JP00005 Izumisano Osaka
Japan Site JP00001 Kamakura Kanagawa
Japan Site JP00035 Kanazawa Ishikawa
Japan Site JP00017 Kasama Ibaraki
Japan Site JP00009 Kasugai Aichi
Japan Site JP00008 Kitakyusyu Fukuoka
Japan Site JP00013 Kitakyusyu Fukuoka
Japan Site JP00040 Kitakyusyu Fukuoka
Japan Site JP00057 Kitakyusyu Fukuoka
Japan Site JP00028 Koga Ibaraki
Japan Site JP00004 Koshigaya Saitama
Japan Site JP00020 Koshigaya Saitama
Japan Site JP00015 Koto-ku Tokyo
Japan Site JP00050 Kure Hiroshima
Japan Site JP00042 Kurume Fukuoka
Japan Site JP00045 Kyoto
Japan Site JP00002 Maebashi Gunma
Japan Site JP00038 Matsuyama Ehime
Japan Site JP00044 Matsuyama Ehime
Japan Site JP00024 Minato-ku Tokyo
Japan Site JP00031 Morioka Iwate
Japan Site JP00006 Musashino Tokyo
Japan Site JP00018 Nagano
Japan Site JP00068 Nagano
Japan Site JP00030 Nagoya Aichi
Japan Site JP00051 Nagoya Aichi
Japan Site JP00053 Naka Ibaraki
Japan Site JP00026 Niigata
Japan Site JP00066 Nishinomiya Hyogo
Japan Site JP00034 Oita
Japan Site JP00055 Okayama
Japan Site JP00056 Osaka
Japan Site JP00061 Osaka
Japan Site JP00060 Ota-ku Tokyo
Japan Site JP00011 Sakai Osaka
Japan Site JP00003 Sakura Chiba
Japan Site JP00007 Sapporo Hokkaido
Japan Site JP00064 Sapporo Hokkaido
Japan Site JP00023 Sashima-gun Ibaraki
Japan Site JP00012 Sendai Miyagi
Japan Site JP00062 Tachikawa Tokyo
Japan Site JP00041 Tajimi Gifu
Japan Site JP00019 Toride Ibaraki
Japan Site JP00010 Toyama
Japan Site JP00021 Toyohashi Aichi
Japan Site JP00046 Tsuchiura Ibaraki
Japan Site JP00036 Ueda Nagano
Japan Site JP00069 Yao Osaka
Japan Site JP00016 Yokohama Kanagawa
Japan Site JP00048 Yokohama Kanagawa

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 the average Hemoglobin (Hb) Baseline and Weeks 18 to 24
Secondary Average Hb from Week 18 to Week 24 Up to Week 24
Secondary Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 18 to 24 Weeks 18 to 24
Secondary Number of participants who achieve the target Hb level at each week Up to Week 24
Secondary Change from baseline in Hb to each post-dosing time point Baseline and Up to Week 52
Secondary Proportion of time points that achieve the target Hb level from Weeks 18 to 24 Up to Week 24
Secondary 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 Up to Week 4
Secondary Quality of life assessed by SF-36 SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey Up to Week 52
Secondary Quality of life assessed by EQ-5D-5L EQ-5D: EuroQol 5 Dimension 5 Levels Up to Week 52
Secondary Quality of life assessed by WPAI:ANS WPAI:ANS: Work Productivity and Activity Impairment Questionnaire: Anaemic Symptoms Up to Week 52
Secondary Quality of life assessed by FACT-An FACT-An: Functional Assessment of Cancer Therapy-Anemia Up to Week 52
Secondary Average Hb from weeks 44 to 52 Up to Week 52
Secondary Change from baseline in the average Hb from weeks 44 to 52 Baseline and Up to Week 52
Secondary Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 44 to 52 Weeks 44 to 52
Secondary Number of participants who achieve the target Hb level at each week Up to Week 52
Secondary Proportion of time points that achieve the target Hb level from Weeks 44 to 52 Up to Week 52
Secondary Average Hematocrit Level Up to Week 52
Secondary Average Reticulocyte Level Up to Week 52
Secondary Average Ferrum Level Up to Week 52
Secondary Average Ferritin Level Up to Week 52
Secondary Average Transferrin Level Up to Week 52
Secondary Average Total Iron Binding Capacity Level Up to Week 52
Secondary Average Soluble Transferrin Receptor Level Up to Week 52
Secondary Average Soluble Transferrin Level Up to Week 52
Secondary Average Reticulocyte Hemoglobin Content Level Up to Week 52
Secondary Number of Occurence of Hospitalizations Up to Week 52
Secondary Duration of Hospitalization Up to week 52
Secondary Number of participants with abnormal Vital signs and/or adverse events related to treatment Up to Week 52
Secondary Safety assessed by body weight Up to Week 52
Secondary Safety assessed by incidence of adverse events Up to Week 52
Secondary Safety assessed by standard 12-lead electrocardiogram Up to Week 52
Secondary Safety assessed by ophthalmological examination: Fundoscopy Up to Week 24
Secondary Safety assessed by ophthalmological examination: optical coherence tomography Up to Week 24
Secondary Safety assessed by ophthalmological examination: visual acuity Up to Week 24
Secondary Number of participants with abnormal Laboratory values and/or adverse events related to treatment Up to Week 52
Secondary Plasma concentration of unchanged ASP1517 Up to Week 24
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