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

NCT ID: NCT05951192

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-02-14

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.

Conditions

Anemia; Renal Insufficiency, Chronic; Renal Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Commercial daprodustat

Prescription of oral daprodustat in accordance with the FDA approved package label.

Group Type: EXPERIMENTAL

Daprodustat

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

JESDUVROQ

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

USRC Kidney Research

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Block, MD

Role: PRINCIPAL_INVESTIGATOR

US Renal Care

Locations

USRC Kidney Research

Lone Tree, Colorado, United States

Countries

United States

Other Identifiers

USRC-2023-001

Identifier Type: -

Identifier Source: org_study_id