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 (ROQ-IT)

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Anemia; Renal Anemia
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • USRC Kidney Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Commercial daprodustat; Prescription of oral daprodustat in accordance with the FDA approved package label.	Drug: 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.; Other Names: JESDUVROQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period	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	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.	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	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	Number of subjects retained on daprodustat therapy from Day 1 through Day 120	120 days
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	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	120 days
The time (in days) from initial and refill prescription to delivery to patient	The time (in days) from initial and refill prescription to delivery to patient	120 days
Average monthly (percent) compliance with daprodustat daily dosing, per subject report.	The average monthly compliance will be calculated from individual subject reported verbal estimates of (percent) compliance with daprodustat daily administration.	120 days

Collaborators and Investigators

• Sponsor: USRC Kidney Research
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Geoffrey Block, MD, US Renal Care

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: daprodustat; mircera
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Hematologic Diseases; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Anemia
• Other Study ID Numbers: USRC-2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No