Anemia of Chronic Kidney Disease
Conditions
Brief summary
This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.
Interventions
DRUGVadadustat
A synthetic, orally bioavailable, small molecule being developed as an inhibitor of hypoxia-inducible factor prolyl-hydroxylases for the treatment of anemia associated with chronic kidney disease. Intervention to be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Standard of care erythropoiesis stimulating agent will be administered to maintain hemoglobin within a target range of 10-11 g/dL.
Sponsors
USRC Kidney Research
Akebia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients greater than or equal to 18 years of age. * Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease. * Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy * Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Exclusion criteria
* Contraindication to receive vadadustat or any of its known constituents per USPI. * Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide). * Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study. * Pregnant at time of consent (per subject self-report).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combination of the hierarchical endpoints of all-cause mortality and all-cause hospitalization. | 18 months | The hierarchical endpoints of all-cause mortality and all cause hospitalization will be analyzed by the win odds method with ranking all cause mortality more important than all cause hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause hospitalization | 18 months | All-cause hospitalization |
| All-cause mortality | 18 months | All-cause mortality |
Countries
United States
Outcome results
None listed