A Phase 2 interventional study of roxadustat and darbepoetin alfa in Renal Anemia Associated With Chronic Renal Failure (CRF), sponsored by Astellas Pharma Inc. Completed at 8 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment
This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.
To evaluate the safety and the dose-response of ASP1517 on hemoglobin (Hb) correction when ASP1517 is applied intermittently in dialysis chronic kidney disease patients with anemia.
To evaluate the treatment effect on Hb maintenance of ASP1517 administered intermittently in dialysis chronic kidney disease patients with anemia.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's enrollment of 130 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants received an oral dose of ASP1517 three times a week.
Drug: roxadustat
Participants received an oral dose of ASP1517 three times a week.
Drug: roxadustat
Participants received an oral dose of ASP1517 three times a week.
Drug: roxadustat
Participants received Darbepoetin alfa intravenously once a week.
Drug: darbepoetin alfa
oral
Also known as: ASP1517
iv
Rate of rise in hemoglobin (g/dL/week)
Time frame: Baseline and at Week-6
Cumulative number of responder patients
Responder is defined as a hemoglobin \>10.0 g/dL and an increase in hemoglobin by \>1.0 g/dL from baseline
Time frame: up to Week-24
Percent of visits at which patients maintain hemoglobin between 10.0-12.0 g/dL after achieving hemoglobin ≥10.0 g/dL for each patients
Time frame: for 28 weeks after dosing
Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit
Time frame: for 28 weeks after dosing
Plan to share: Yes — 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 products 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Data sharing details ↗ · www.clinicaltrials.astellas.com
Ran from Mar 2013 to primary completion in Sep 2014, 17 months.
Of 66 phase 2 interventional studies under Kidney Failure, Chronic, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's 17 months is below that.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Roxadustat