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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
USRC Kidney Research
Lone Tree, Colorado, United States
Start Date
July 1, 2023
Primary Completion Date
February 14, 2024
Completion Date
February 14, 2024
Last Updated
May 24, 2024
161
ACTUAL participants
Daprodustat
DRUG
Lead Sponsor
USRC Kidney Research
Collaborators
NCT05012111
NCT03520647
Data Source & Attribution
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