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

NCT05951192 | Completed Phase 4 FDA Drug

• 1 other identifier: USRC-2023-001
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Renal Insufficiency, Chronic; Renal Anemia

Keywords

daprodustat; mircera

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin from baseline to the effectiveness evaluation period

  Change in hemoglobin from baseline (defined as the mean of all available hemoglobin values obtained in the 30 days prior to Day 1) to the effectiveness evaluation period (mean of all available hemoglobin values obtained in the 30 days prior to Day 120).

  120 days

Secondary Outcomes (8)

• The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period

  120 days

• The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period

  120 days

• Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period.

  120 days

• Number of dose adjustments in daprodustat per patient during the treatment period

  120 days

• Number of subjects retained on daprodustat therapy from Day 1 through Day 120

  120 days

Study Arms (1)

Commercial daprodustat

EXPERIMENTAL

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

Drug: Daprodustat

Interventions

Daprodustat 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.

Also known as: JESDUVROQ

Commercial daprodustat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• USRC Kidney Research: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

USRC Kidney Research

Lone Tree, Colorado, 80124, United States

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

GSK1278863

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Geoffrey Block, MD

  US Renal Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 18, 2023
• Study Start: July 1, 2023
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)