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A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis 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: NCT02952092
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
FibroGen
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.

Condition or disease Intervention/treatment Phase
Hemodialysis Chronic Kidney Disease Patients With Anemia Drug: roxadustat Drug: Darbepoetin alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : March 13, 2018
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASP1517 Group
Subjects will take the study drug at two- or three-day intervals.
Drug: roxadustat
Oral
Other Name: ASP1517

Experimental: Darbepoetin alfa Group
Subjects will take the study drug once a week.
Drug: Darbepoetin alfa
Intravenous




Primary Outcome Measures :
  1. Change from baseline in the average hemoglobin (Hb) [ Time Frame: Baseline and Weeks 18 to 24 ]

Secondary Outcome Measures :
  1. Average Hb from Week 18 to Week 24 [ Time Frame: Week 18 to 24 ]
  2. Proportion of participants with the target Hb level from Week 18 to Week 24 [ Time Frame: Week 18 to 24 ]
  3. Proportion of participants with the target Hb level at each week [ Time Frame: Up to Week 24 ]
  4. Change from week 0 in Hb levels to each week [ Time Frame: Up to Week 24 ]
  5. Proportion of measurement points with the target Hb level from Week 18 to Week 24 [ Time Frame: Week 18 to 24 ]
  6. 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 [ Time Frame: Up to Week 4 ]
  7. Average hematocrit level [ Time Frame: Up to Week 24 ]
  8. Average reticulocyte level [ Time Frame: Up to Week 24 ]
  9. Average iron (Fe) level [ Time Frame: Up to Week 24 ]
  10. Average ferritin level [ Time Frame: Up to Week 24 ]
  11. Average transferrin level [ Time Frame: Up to Week 24 ]
  12. Average total iron binding capacity level [ Time Frame: Up to Week 24 ]
  13. Average soluble transferrin receptor level [ Time Frame: Up to Week 24 ]
  14. Average transferrin saturation level [ Time Frame: Up to Week 24 ]
  15. Average reticulocyte hemoglobin content level [ Time Frame: Up to Week 24 ]
  16. Quality of life assessed by SF-36 [ Time Frame: Up to Week 24 ]
    SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey

  17. Quality of life assessed by EQ-5D-5L [ Time Frame: Up to Week 24 ]
    EQ-5D-5L: EuroQol 5 Dimension 5-Levels

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

  19. Number of hospitalizations [ Time Frame: Up to Week 24 ]
  20. Duration of hospitalizations [ Time Frame: Up to Week 24 ]
  21. Plasma concentration of unchanged ASP1517 [ Time Frame: Up to Week 24 ]
  22. Safety assessed by incidence of adverse events [ Time Frame: Up to Week 24 ]
  23. Number of participants with abnormal Laboratory values and/or adverse events related to treatment [ Time Frame: Up to Week 24 ]
  24. Number of participants with abnormal Vital signs and/or adverse events related to treatment [ Time Frame: Up to Week 24 ]
  25. Number of participants with abnormal 12-lead electrocardiogram (ECG) values [ Time Frame: Up to Week 24 ]
    Any clinically significant adverse changes on the ECG will be reported as adverse events.

  26. Safety assessed by ophthalmological examination: fundoscopy [ Time Frame: Up to Week 24 ]
  27. Safety assessed by ophthalmological examination: Optical coherence tomography [ Time Frame: Up to Week 24 ]
  28. Safety assessed by ophthalmological examination: visual acuity [ 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 with renal anemia who have been receiving recombinant human erythropoietin (rHuEPO, two times weekly or three times weekly) or darbepoetin alfa (intravenous treatment) within the doses approved in Japan for more than 8 weeks before the screening assessment
  • Mean of the subject's two most recent Hb values before dialysis after the longest dialysis interval during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
  • Either transferrin saturation (TSAT) ≥ 20% or serum ferritin ≥ 100 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 untreated and macular edema untreated
  • 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
  • History of pure red cell aplasia
  • 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) and/or ophthalmological surgery 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

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): NCT02952092


Locations
Show Show 57 study locations
Sponsors and Collaborators
Astellas Pharma Inc
FibroGen
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02952092    
Other Study ID Numbers: 1517-CL-0307
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 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:
ASP1517
Renal anemia
Hemodialysis
Roxadustat
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics