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
• Trial end date: 2024-02-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: USRC Kidney Research
• Collaborator: GlaxoSmithKline

Criteria

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.