Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05951192
Other study ID # USRC-2023-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 1, 2023
Est. completion date February 14, 2024

Study information

Verified date May 2024
Source USRC Kidney Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date February 14, 2024
Est. primary completion date February 14, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States USRC Kidney Research Lone Tree Colorado

Sponsors (2)

Lead Sponsor Collaborator
USRC Kidney Research GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Completed NCT01432717 - Study of ACE-536 in Healthy Postmenopausal Women Phase 1
Completed NCT01458028 - Age and Gender Effects on the Pharmacokinetics of BAY85-3934 Phase 1