Clinical Trials Logo
  1. Home
  2. Anemia
  3. NCT03140722
  4. Details
NCT03140722 Clinical Trial

Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

Anemia Clinical Trial

Official title:
Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03140722
Other study ID # AKB-6548-CI-0018
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 2, 2017
Est. completion date March 21, 2018

Study information
Verified date February 2021
Source Akebia Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date March 21, 2018
Est. primary completion date March 21, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male and female subjects =18 years of age - Receiving chronic maintenance hemodialysis for end-stage kidney disease - Currently receiving epoetin alfa for anemia - Hb between 8.5 and 10.0 g/dL during screening Exclusion Criteria: - Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss - Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia - Red blood cell transfusion within 4 weeks prior to or during screening - Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• vadadustat
vadadustat
• epoetin alfa
epoetin alfa

Locations
Country Name City State
United States Research Site Bakersfield California
United States Research Site Bronx New York
United States Research Site Detroit Michigan
United States Research Site El Paso Texas
United States Research Site Elk Grove California
United States Research Site Encino California
United States Research Site Escondido California
United States Research Site Houston Texas
United States Research Site Lynwood California
United States Research Site Miami Florida
United States Research Site Newport News Virginia
United States Research Site Norfolk Virginia
United States Research Site Orlando Florida
United States Research Site Philadelphia Pennsylvania
United States Research Site San Diego California
United States Research Site San Luis Obispo California
United States Research Site Statesboro Georgia
United States Research Site Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period Baseline; up to 20 weeks
Secondary Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period Baseline; up to 20 weeks
Secondary Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period Baseline; up to 20 weeks
Secondary Number of Participants Receiving Epoetin Alfa Rescue up to 20 weeks
Secondary Number of Participants Receiving Red Blood Cell Transfusion up to 20 weeks
Secondary Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor up to 20 weeks
Secondary Mean Weekly Dose of Intravenous Elemental Iron Administered up to 20 weeks
Secondary Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin =100 Nanograms Per Milliliter and Transferrin Saturation =20%) up to 20 weeks
Secondary Number of Participants Utilizing Resources up to 20 weeks
Secondary Number of Participants With Treatment-emergent Adverse Events Treatment-emergent adverse events were collected in all participants enrolled in the study. up to 24 weeks
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 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 NCT02912494 - A Phase III 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 NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
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 NCT01458028 - Age and Gender Effects on the Pharmacokinetics of BAY85-3934 Phase 1
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A