CompletedPhase 4

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

United States161 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult patients ≥18 years old.
✓. Diagnosis of end stage kidney disease and receiving maintenance dialysis (in-center hemodialysis or peritoneal dialysis) for ≥ 4 months.
✓. Has received at least a single dose of Mircera within 45 days prior to prescription of Daprodustat by treating physician.
✓. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion criteria

✕. A known allergy or intolerance to daprodustat or any of its constituents.
✕. Uncontrolled hypertension.
✕. Active malignancy as documented in electronic medical record.
✕. Concomitant use of a strong CYP2C8 inhibitor such as gemfibrozil.
✕. Severe hepatic impairment as documented in the electronic medical record.

What they're measuring

Change in hemoglobin from baseline to the effectiveness evaluation period

Timeframe: 120 days

Trial details

NCT IDNCT05951192

SponsorUSRC Kidney Research

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-02-14

View on ClinicalTrials.gov More Anemia trials