A Phase 4 interventional study of Daprodustat in Anemia, Renal Insufficiency, Chronic and Renal Anemia, sponsored by USRC Kidney Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by USRC Kidney Research · Phase 4, Interventional, and Treatment
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 161 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
Prescription of oral daprodustat in accordance with the FDA approved package label.
Drug: Daprodustat
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.
Also known as: JESDUVROQ
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).
Time frame: 120 days
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
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
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.
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
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
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
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
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.
The average monthly compliance will be calculated from individual subject reported verbal estimates of (percent) compliance with daprodustat daily administration.
Time frame: 120 days
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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USRC Kidney Research