Clinical trial NCT03140722: Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anemia
Dialysis-Dependent Chronic Kidney Disease
Keywords: anemia
kidney
dialysis-dependent chronic kidney disease
CKD
DD-CKD
renal
vadadustat
AKB-6548
hypoxia-inducible factor
HIF
hypoxia-inducible factor prolyl-hydroxylase inhibitor
HIF-PHI
hyporesponder
hyporesponsive
epoetin alfa
hemoglobin
erythropoiesis stimulating agent
ESA
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.)


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
timeFrame: Baseline; up to 20 weeks
Secondary outcomes:
measure: Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period
timeFrame: Baseline; up to 20 weeks
measure: Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period
timeFrame: Baseline; up to 20 weeks
measure: Number of Participants Receiving Epoetin Alfa Rescue
timeFrame: up to 20 weeks
measure: Number of Participants Receiving Red Blood Cell Transfusion
timeFrame: up to 20 weeks
measure: Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor
timeFrame: up to 20 weeks
measure: Mean Weekly Dose of Intravenous Elemental Iron Administered
timeFrame: up to 20 weeks
measure: Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)
timeFrame: up to 20 weeks
measure: Number of Participants Utilizing Resources
timeFrame: up to 20 weeks
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Elk Grove
country: United States
facility: Research Site
state: California
city: Encino
country: United States
facility: Research Site
state: California
city: Escondido
country: United States
facility: Research Site
state: California
city: Lynwood
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Luis Obispo
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Statesboro
country: United States
facility: Research Site
state: Georgia
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Bronx
country: United States
facility: Research Site
state: New York
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Sponsor GmbH
name: Akebia Therapeutics
role: STUDY_DIRECTOR
References: