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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02964936
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
FibroGen
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: roxadustat Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 11, 2017
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASP1517 Low dose group
Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
Drug: roxadustat
Oral administration
Other Name: ASP1517

Experimental: ASP1517 High dose group
Study drug will be dosed three times weekly for 24 weeks and dose adjustments will be made during the study.
Drug: roxadustat
Oral administration
Other Name: ASP1517




Primary Outcome Measures :
  1. Change from baseline in hemoglobin (Hb) response rate [ Time Frame: Baseline and week 24 ]
    Hb response is defined as reaching target values for Hb.


Secondary Outcome Measures :
  1. Change from baseline in the average Hb from Week 18 to Week 24 [ Time Frame: Baseline and Weeks 18 to 24 ]
  2. Proportion of participants who achieve the target Hb level at the average of Week 18 to 24 [ Time Frame: Weeks 18 to 24 ]
    Hb response defined as average Hb within the target range in this outcome

  3. 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 [ Time Frame: Up to Week 4 ]
  4. Proportion of measurement points with the target Hb level [ Time Frame: Weeks 18 to 24 ]
  5. Proportion of participants who achieves the target Hb level at each week [ Time Frame: Up to Week 24 ]
  6. Proportion of participants who achieves the lower limit of the target Hb level [ Time Frame: Up to Week 24 ]
  7. Time to achieve the lower limit of the target Hb level [ Time Frame: Up to Week 24 ]
  8. Change from baseline in Hb level to each week [ Time Frame: Baseline and Up to Week 24 ]
  9. Quality of life assessed by EQ-5D-5L [ Time Frame: Up to Week 24 ]
    EQ-5D: EuroQol 5 Dimension 5 Levels

  10. Quality of life assessed by FACT-An [ Time Frame: Up to Week 24 ]
    FACT-An: Functional Assessment of Cancer Therapy-Anemia

  11. Number of participants with abnormal Vital signs and/or adverse events related to treatment [ Time Frame: Up to Week 24 ]
  12. Safety assessed by body weight [ Time Frame: Up to Week 24 ]
  13. Safety assessed by incidence of adverse events [ Time Frame: Up to Week 24 ]
  14. Safety assessed by standard 12-lead electrocardiogram [ Time Frame: Up to Week 24 ]
  15. Number of participants with abnormal Laboratory values and/or adverse events related to treatment [ Time Frame: Up to Week 24 ]
  16. Plasma concentration of unchanged ASP1517 [ Time Frame: Up to Week 24 ]
  17. Average hematocrit level [ Time Frame: Up to Week 24 ]
  18. Average reticulocyte level [ Time Frame: Up to Week 24 ]
  19. Average iron (Fe) level [ Time Frame: Up to Week 24 ]
  20. Average ferritin level [ Time Frame: Up to Week 24 ]
  21. Average transferrin level [ Time Frame: Up to Week 24 ]
  22. Average total iron binding capacity level [ Time Frame: Up to Week 24 ]
  23. Average soluble transferrin receptor level [ Time Frame: Up to Week 24 ]
  24. Average transferrin saturation level [ Time Frame: Up to Week 24 ]
  25. Average reticulocyte hemoglobin content level [ Time Frame: Up to Week 24 ]
  26. Number of hospitalizations [ Time Frame: Up to Week 24 ]
  27. Duration of hospitalizations [ Time Frame: Up to Week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964936


Locations
Show Show 38 study locations
Sponsors and Collaborators
Astellas Pharma Inc
FibroGen
Investigators
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Study Director: Medical Director Astellas Pharma Inc
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02964936    
Other Study ID Numbers: 1517-CL-0314
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc:
Anemia
Non-dialysis chronic kidney disease
Roxadustat
ASP1517
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency