Anemia Clinical Trial
— ROQ-ITOfficial 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
Verified date | May 2024 |
Source | USRC Kidney Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Completed |
Enrollment | 161 |
Est. completion date | February 14, 2024 |
Est. primary completion date | February 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult patients =18 years old. 2. Diagnosis of end stage kidney disease and receiving maintenance dialysis (in-center hemodialysis or peritoneal dialysis) for = 4 months. 3. Has received at least a single dose of Mircera within 45 days prior to prescription of Daprodustat by treating physician. 4. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure. Exclusion Criteria: 1. A known allergy or intolerance to daprodustat or any of its constituents. 2. Uncontrolled hypertension. 3. Active malignancy as documented in electronic medical record. 4. Concomitant use of a strong CYP2C8 inhibitor such as gemfibrozil. 5. Severe hepatic impairment as documented in the electronic medical record. |
Country | Name | City | State |
---|---|---|---|
United States | USRC Kidney Research | Lone Tree | Colorado |
Lead Sponsor | Collaborator |
---|---|
USRC Kidney Research | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 120 days | |
Secondary | 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 | 120 days | |
Secondary | 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 | 120 days | |
Secondary | 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. | 120 days | |
Secondary | Number of dose adjustments in daprodustat per patient during the treatment period | Number of dose adjustments in daprodustat per patient during the treatment period | 120 days | |
Secondary | 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 | 120 days | |
Secondary | 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 | 120 days | |
Secondary | 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 | 120 days | |
Secondary | 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. | 120 days |
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