AnemiaPhase 4ROQ-ITNCT05951192
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
A Phase 4 study testing Daprodustat in people with Anemia and Renal Insufficiency, Chronic, run by USRC Kidney Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Renal Insufficiency, Chronic, Renal Anemia
- What is being tested?
- Daprodustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 14 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A known allergy or intolerance to daprodustat or any of its constituents.
- Uncontrolled hypertension.
- Active malignancy as documented in electronic medical record.
- Concomitant use of a strong CYP2C8 inhibitor such as gemfibrozil.
- Severe hepatic impairment as documented in the electronic medical record.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Investigator-initiated, multicenter, prospective, interventional study to determine the clinical and operational effectiveness of transitioning from intravenous or subcutaneous Mircera to oral daily daprodustat as assessed by change in hemoglobin. This trial will be conducted at up to 40 United States Renal Care sites in the United States and will enroll approximately 200 patients (~150 in-center hemodialysis and ~50 home dialysis patients).
Participants who are prescribed daprodustat by their treating physician and have taken at least a single dose of daprodustat will be considered enrolled into the clinical trial. After the prescription of daprodustat by the treating physician, each subject will be followed prospectively for a treatment period of approximately 120 days.
Subjects taking daprodustat will not have any in-person study related visits and will follow their usual schedule with regard to standard of care. Standard of care laboratory assessments as ordered by the primary nephrologist will be utilized. Twice monthly hemoglobin collection and monitoring will be required as part of the standard of care laboratory assessments.
- Conditions
- Anemia, Renal Insufficiency, Chronic, Renal Anemia
- Being tested
- Daprodustat
- Keywords
- daprodustat, mircera
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaprodustatDrug
Also called JESDUVROQ
Commercially manufactured daprodustat (JESDUVROQ) is provided in tablet strengths of 1, 2, 4, 6 and 8 mg. Tablets will be taken whole and patients will be instructed not to cut, crush, or chew tablets.
| Study group | Role | What they receive |
|---|---|---|
| Commercial daprodustat | Experimental | Prescription of oral daprodustat in accordance with the FDA approved package label. Receives: Drug: Daprodustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin from baseline to the effectiveness evaluation period
Change in hemoglobin from baseline (defined as the mean of all available hemoglobin values obtained in the 30 days prior to Day 1) to the effectiveness evaluation period (mean of all available hemoglobin values obtained in the 30 days prior to Day 120).
Measured: 120 days
Secondary outcomes (8)
The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period
The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period
Measured: 120 days
The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period
The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period
Measured: 120 days
Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period.
Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period.
Measured: 120 days
Number of dose adjustments in daprodustat per patient during the treatment period
Number of dose adjustments in daprodustat per patient during the treatment period
Measured: 120 days
Number of subjects retained on daprodustat therapy from Day 1 through Day 120
Number of subjects retained on daprodustat therapy from Day 1 through Day 120
Measured: 120 days
The number/proportion of subjects who receive a refill prescription with the correct prescribed dose with no gap (0 days) in drug supply from the previous prescription
The number/proportion of subjects who receive a refill prescription with the correct prescribed dose with no gap (0 days) in drug supply from the previous prescription
Measured: 120 days
The time (in days) from initial and refill prescription to delivery to patient
The time (in days) from initial and refill prescription to delivery to patient
Measured: 120 days
Average monthly (percent) compliance with daprodustat daily dosing, per subject report.
The average monthly compliance will be calculated from individual subject reported verbal estimates of (percent) compliance with daprodustat daily administration.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jul 2023
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- USRC Kidney Research
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Geoffrey Block, MD, Principal investigator, US Renal Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951192
- Sponsor's protocol ID
- USRC-2023-001
- Acronym
- ROQ-IT
- Status last verified
- May 2024
- First submitted
- 2 Jun 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05951192
- Acronym / sponsor ID
- ROQ-IT / USRC-2023-001
- Conditions
- Anemia, Renal Insufficiency, Chronic, Renal Anemia
- Keywords
- daprodustat, mircera
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- USRC Kidney ResearchResearch network
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigator-initiated, multicenter, prospective, interventional study to determine the clinical and operational effectiveness of transitioning from intravenous or subcutaneous Mircera to oral daily daprodustat as assessed by change in hemoglobin. This trial will be conducted at up to 40 United States Renal Care sites in the United States and will enroll approximately 200 patients (~150 in-center hemodialysis and ~50 home dialysis patients).
Participants who are prescribed daprodustat by their treating physician and have taken at least a single dose of daprodustat will be considered enrolled into the clinical trial. After the prescription of daprodustat by the treating physician, each subject will be followed prospectively for a treatment period of approximately 120 days.
Subjects taking daprodustat will not have any in-person study related visits and will follow their usual schedule with regard to standard of care. Standard of care laboratory assessments as ordered by the primary nephrologist will be utilized. Twice monthly hemoglobin collection and monitoring will be required as part of the standard of care laboratory assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Commercial daprodustat | Experimental | Drug: DaprodustatPrescription of oral daprodustat in accordance with the FDA approved package label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- A known allergy or intolerance to daprodustat or any of its constituents.
- Uncontrolled hypertension.
- Active malignancy as documented in electronic medical record.
- Concomitant use of a strong CYP2C8 inhibitor such as gemfibrozil.
- Severe hepatic impairment as documented in the electronic medical record.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaprodustatAlso: JESDUVROQCommercially manufactured daprodustat (JESDUVROQ) is provided in tablet strengths of 1, 2, 4, 6 and 8 mg. Tablets will be taken whole and patients will be instructed not to cut, crush, or chew tablets. | Drug | Commercial daprodustat |
Primary outcome
Change in hemoglobin from baseline to the effectiveness evaluation period
Time frame: 120 days
Change in hemoglobin from baseline (defined as the mean of all available hemoglobin values obtained in the 30 days prior to Day 1) to the effectiveness evaluation period (mean of all available hemoglobin values obtained in the 30 days prior to Day 120).
8 secondary outcomes
The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period
Time frame: 120 days
The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period
Time frame: 120 days
Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period.
Time frame: 120 days
Number of dose adjustments in daprodustat per patient during the treatment period
Time frame: 120 days
Number of subjects retained on daprodustat therapy from Day 1 through Day 120
Time frame: 120 days
The number/proportion of subjects who receive a refill prescription with the correct prescribed dose with no gap (0 days) in drug supply from the previous prescription
Time frame: 120 days
The time (in days) from initial and refill prescription to delivery to patient
Time frame: 120 days
Average monthly (percent) compliance with daprodustat daily dosing, per subject report.
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Block, MD principal investigator
US Renal Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daprodustat in people with Anemia and Renal Insufficiency, Chronic, run by USRC Kidney Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin from baseline to the effectiveness evaluation period (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.