Last updated: 11/11/2025 06:00:12
Real World Data Use of Daprodustat in Japanese Participants
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Patient Characteristics and Anemia Management Inpatient with CKD Anemia Treated by Daprodustat: An Observational Study in Japan
Trial description: The study will evaluate the current practice and treatment pattern of daprodustat, and characteristics of daprodustat users in Japan, and their management for anemia in chronic kidney disease (CKD) anemia participants.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with Clinical Characteristics for Anemia Management in CKD Participants on Dialysis or Non-Dialysis
Timeframe: 26 weeks pre-dose and 28 weeks post-dose
Number of participants with Treatment Patterns for anemia Management in CKD Participants on Dialysis or Non-Dialysis
Timeframe: 26 weeks pre-dose and 28 weeks post-dose
Secondary outcomes:
Number of participants with Clinical Characteristics and Treatment Patterns for Anemia Management in Subgroups Stratified by CKD Stages and at Baseline Haemoglobin (Hb) Range
Timeframe: Baseline and 28 weeks post-dose
Hb Values, Between Baseline and 28 Weeks After Initiation, in CKD Anemia Participants on Dialysis or Non-Dialysis Who Initiate Daprodustat After Switching from ESAs
Timeframe: Baseline and 28 weeks post-dose
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2024-16-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Masashi Takano, Kazuko Suzuki, Sakiyo Tsukamoto, Yasuo Nakajima, Hirofumi Ozeki, Masao Yarita, Ai Hayashi. Characteristics and management of patients with renal anaemia treated with daprodustat: an observational study in Japan. Current medical research and opinion. 2025-Sep-19;41(8): 1465-1474. doi:10.1080/03007995.2025.2556321 http://dx.doi.org/10.1080/03007995.2025.2556321
PMID: 40970460
DOI: 10.1080/03007995.2025.2556321
Medical condition
Anaemia
Product
daprodustat
Collaborators
Not applicable
Study date(s)
November 2023 to January 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
No
- Primary objective and Secondary objective 1
- CKD anemia on dialysis with daprodustat Cohort (hereinafter called "aCKDDap- DD cohort”):
- Having record of renal transplantation (recipient) during the baseline period
- Having record of daprodustat treatment during the baseline period
Inclusion and exclusion criteria
Inclusion criteria:
- Primary objective and Secondary objective 1 CKD anemia on dialysis with daprodustat Cohort (hereinafter called "aCKDDap- DD cohort”):
- At least one prescribing daprodustat, and first prescription will be defined as the index date
- Aged 15 and above at index date
- estimated glomerular filtration rate (eGFR) less than (<) 60 millilitre/minute (ml/min)/1.73 metre square (m^2) measured for at least twice during baseline period*
- At least one Hb value available during the baseline period
- At least one record of CKD anemia identified by disease code during baseline period
- At least one record of dialysis during baseline period
- At least 26 weeks of continuous enrolment prior to index date CKD anemia on non-dialysis with daprodustat Cohort (hereinafter called "aCKDDap- ND cohort”):
- Same criteria of aCKD-Dap-DD cohort except dialysis
- Having no records of dialysis during baseline period Secondary objective 2 CKD anemia on dialysis with daprodustat Switch Cohort (hereinafter called "aCKD-Dap-DD Switch cohort”):
- At least one prescribing daprodustat during index periods, and first prescription will be defined as the index date
- Aged 15 and above at index date
- eGFR<60 ml/min/1.73 m2 measured for at least twice during and baseline period
- At least one record of CKD anemia identified by disease code during baseline period At least 90 days prescription of any erythropoietin stimulating agent (ESAs) during the baseline period
- At least one Hb value available during the baseline period
- At least one Hb value available within 23-28 week after index date*
- At least one record of dialysis during baseline period
- At least 26 weeks of continuous enrolment prior to index date *: It is possible that the inclusion criteria could induce selection bias due to automatic/systematic exclusion of patients who do not have Hb values at 23-28 weeks different from those that do. However, this is expected a relatively limited proportion of missing data because most of patients have been entered Hb data frequently in feasibility check. CKD anemia on non-dialysis with daprodustat Switch Cohort (hereinafter called "aCKD-Dap-ND Switch cohort”):
- Same criteria of aCKD-Dap-DD Switch cohort except dialysis
- Having no records of dialysis during baseline period
Exclusion criteria:
- Having record of renal transplantation (recipient) during the baseline period
- Having record of daprodustat treatment during the baseline period For exploratory objective 2
- Having record of renal transplantation (recipient) during period for analysis
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2024-16-01
Actual study completion date
2024-16-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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