NCT05951192

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: USRC Kidney Research · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-02-14
• Completion: 2024-02-14
• First posted: 2023-07-18
• Last updated: 2024-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study