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A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis 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: NCT02988973
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
FibroGen
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief 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).

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

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia
Actual Study Start Date : January 12, 2017
Actual Primary Completion Date : September 13, 2019
Actual Study Completion Date : March 26, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: rHuEPO or DA to ASP1517
Participants will receive roxadustat according to the prior randomization treatment, with starting doses of 70mg thrice weekly (TIW) to participants on <4500 IU/week of rHuEPO or <20 microgram (μg)/week of darbepoetin alfa (DA) and 100mg TIW to participants on ≥4500 IU/week rHuEPO or ≥ 20 μg/week DA. Participants roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.
 Drug: roxadustat
Oral administration
Other Name: ASP1517
Experimental: rHuEPO or DA to DA
Participants will receive DA according to the prior randomization treatment, with starting doses of 15 μg/2weeks to participants on ≤ 1500 IU/week of rHuEPO or <11.25 microgram (μg)/week of DA, 30μg/2weeks to participants on >1500 to <6000 IU/week of rHuEPO or ≥ 11.25 to < 22.5 μg/week of DA, 60μg/2weeks to participants on ≥ 6000 IU/week of rHuEPO or ≥ 22.5 to < 37.5 μg/week of DA, 90μg/2weeks to participants on ≥ 37.5 to < 52.5 μg/week of DA, 120μg/2weeks to participants on ≥ 52.5 to < 75 μg/week of DA, 180μg/2weeks to participants on ≥ 75 μg/week of DA. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 15, 30, 60, 90, 120, and 180 μg.
 Drug: DA
Subcutaneous administration
Experimental: Epoetin beta pegol to ASP1517
Participants will receive roxadustat according to the prior registration treatment, with starting doses of 70mg thrice weekly (TIW) to participants on ≤100 μg/week of Epoetin beta pegol and 100mg TIW to participants on >100 μg/week of Epoetin beta pegol. Participant's roxadustat dosage will be adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps will be as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300 mg.
 Drug: roxadustat
Oral administration
Other Name: ASP1517


Outcome Measures
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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: Up to Week 24 ]
  2. Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 18 to 24 [ Time Frame: Weeks 18 to 24 ]
  3. Number of participants who achieve the target Hb level at each week [ Time Frame: Up to Week 24 ]
  4. Change from baseline in Hb to each post-dosing time point [ Time Frame: Baseline and Up to Week 52 ]
  5. Proportion of time points that achieve the target Hb level from Weeks 18 to 24 [ Time Frame: Up to Week 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. Quality of life assessed by SF-36 [ Time Frame: Up to Week 52 ]
    SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey

  8. Quality of life assessed by EQ-5D-5L [ Time Frame: Up to Week 52 ]
    EQ-5D: EuroQol 5 Dimension 5 Levels

  9. Quality of life assessed by WPAI:ANS [ Time Frame: Up to Week 52 ]
    WPAI:ANS: Work Productivity and Activity Impairment Questionnaire: Anaemic Symptoms

  10. Quality of life assessed by FACT-An [ Time Frame: Up to Week 52 ]
    FACT-An: Functional Assessment of Cancer Therapy-Anemia

  11. Average Hb from weeks 44 to 52 [ Time Frame: Up to Week 52 ]
  12. Change from baseline in the average Hb from weeks 44 to 52 [ Time Frame: Baseline and Up to Week 52 ]
  13. Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 44 to 52 [ Time Frame: Weeks 44 to 52 ]
  14. Number of participants who achieve the target Hb level at each week [ Time Frame: Up to Week 52 ]
  15. Proportion of time points that achieve the target Hb level from Weeks 44 to 52 [ Time Frame: Up to Week 52 ]
  16. Average Hematocrit Level [ Time Frame: Up to Week 52 ]
  17. Average Reticulocyte Level [ Time Frame: Up to Week 52 ]
  18. Average Ferrum Level [ Time Frame: Up to Week 52 ]
  19. Average Ferritin Level [ Time Frame: Up to Week 52 ]
  20. Average Transferrin Level [ Time Frame: Up to Week 52 ]
  21. Average Total Iron Binding Capacity Level [ Time Frame: Up to Week 52 ]
  22. Average Soluble Transferrin Receptor Level [ Time Frame: Up to Week 52 ]
  23. Average Soluble Transferrin Level [ Time Frame: Up to Week 52 ]
  24. Average Reticulocyte Hemoglobin Content Level [ Time Frame: Up to Week 52 ]
  25. Number of Occurence of Hospitalizations [ Time Frame: Up to Week 52 ]
  26. Duration of Hospitalization [ Time Frame: Up to week 52 ]
  27. Number of participants with abnormal Vital signs and/or adverse events related to treatment [ Time Frame: Up to Week 52 ]
  28. Safety assessed by body weight [ Time Frame: Up to Week 52 ]
  29. Safety assessed by incidence of adverse events [ Time Frame: Up to Week 52 ]
  30. Safety assessed by standard 12-lead electrocardiogram [ Time Frame: Up to Week 52 ]
  31. Safety assessed by ophthalmological examination: Fundoscopy [ Time Frame: Up to Week 24 ]
  32. Safety assessed by ophthalmological examination: optical coherence tomography [ Time Frame: Up to Week 24 ]
  33. Safety assessed by ophthalmological examination: visual acuity [ Time Frame: Up to Week 24 ]
  34. Number of participants with abnormal Laboratory values and/or adverse events related to treatment [ Time Frame: Up to Week 52 ]
  35. Plasma concentration of unchanged ASP1517 [ Time Frame: Up to Week 24 ]

Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT02988973


Locations
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Sponsors and Collaborators
Astellas Pharma Inc
FibroGen
Investigators
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Study Director: Medical Director Astellas Pharma Inc
More Information
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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: NCT02988973    
Other Study ID Numbers: 1517-CL-0310
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
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:
Roxadustat
Anemia
Non-dialysis chronic kidney disease
ASP1517
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency