Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Renal Insufficiency, Chronic
Renal Anemia
Keywords: daprodustat
mircera
Lead sponsor: USRC Kidney Research
Sponsor class: NETWORK
Collaborators: name: GlaxoSmithKline
First posted: 2023-07-18
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change in hemoglobin from baseline to the effectiveness evaluation period
timeFrame: 120 days
Secondary outcomes:
measure: The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period
timeFrame: 120 days
measure: The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period
timeFrame: 120 days
measure: Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period.
timeFrame: 120 days
measure: Number of dose adjustments in daprodustat per patient during the treatment period
timeFrame: 120 days
measure: Number of subjects retained on daprodustat therapy from Day 1 through Day 120
timeFrame: 120 days
measure: 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
timeFrame: 120 days
measure: The time (in days) from initial and refill prescription to delivery to patient
timeFrame: 120 days
measure: Average monthly (percent) compliance with daprodustat daily dosing, per subject report.
timeFrame: 120 days
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: USRC Kidney Research
state: Colorado
Study officials:
affiliation: US Renal Care
name: Geoffrey Block, MD
role: PRINCIPAL_INVESTIGATOR
References: