Last updated: 06/16/2025 11:10:13
An observational study to confirm the safety of Duvroq in daily clinical practice
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: DUVROQ Tablet General Drug Use Investigation (Renal Anaemia)
Trial description: The study aims to confirm the safety of Duvroq tablets in daily clinical practice for the treatment of renal anemia. This study will include participants, who receive Duvroq for the first time in order to treat renal anemia. The observation period per participant will be for 52 weeks from the start date of Duvroq administration and the total duration of the study will be 2 years. Approximately 1500 participants will be enrolled in this study.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with adverse events (AEs)
Timeframe: Up to Week 52
Occurrences of adverse drug reactions (ADRs)
Timeframe: Up to Week 52
Occurrences of malignant tumor
Timeframe: Up to 2 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1500
Primary completion date:
2022-15-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
anemia
Product
daprodustat
Collaborators
Not applicable
Study date(s)
November 2020 to July 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Participants receiving Duvroq for the first time in order to treat renal anemia.
- An informed consent should be obtained from the participants or participant’s representative.
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants receiving Duvroq for the first time in order to treat renal anemia.
- An informed consent should be obtained from the participants or participant’s representative.
Exclusion criteria:
- Not applicable.
Trial location(s)
Study documents
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
Recruitment complete
Actual primary completion date
2022-15-07
Actual study completion date
2022-15-07
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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