NCT05951192CompletedPhase 4
A Prospective Interventional Study Assessing the Clinical and Operational Effectiveness of Transitioning From Mircera to Daprodustat for the Treatment of Anemia in End Stage Kidney Disease
Source: ClinicalTrials.gov · Last updated 24 May 2024
Brief summary (registry, in English)
Investigator-initiated, interventional, prospective study to assess the clinical and operational effectiveness of daprodustat in adult patients receiving in center hemodialysis or peritoneal home dialysis who are transitioning from Mircera to daprodustat.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 161 (actual)
- First submitted
- 2 Jun 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 14 Feb 2024
- Lead sponsor
- USRC Kidney Research
- Diseases
- Chronic kidney disease
- NCT number
- NCT05951192
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 161
- From 1 Jul 2023 to the primary completion date, 14 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of a strong CYP2C8 inhibitor such as gemfibrozil.
Other illness
- A known allergy or intolerance to daprodustat or any of its constituents.
- Uncontrolled hypertension.
- Active malignancy as documented in electronic medical record.
- Severe hepatic impairment as documented in the electronic medical record.
Who the study is looking for
- Adult patients ≥18 years old.
- Diagnosis of end stage kidney disease and receiving maintenance dialysis (in-center hemodialysis or peritoneal dialysis) for ≥ 4 months.
- Has received at least a single dose of Mircera within 45 days prior to prescription of Daprodustat by treating physician.
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| USRC Kidney Research Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.