Anemia Associated With Chronic Kidney Disease
Conditions
Brief summary
The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.
Detailed description
This is a multi-center, single-arm, open-label study assessing the safety of a phased transition from Epogen to three times per week vadadustat (TIW-V) for the treatment of anemia in subjects receiving in-center hemodialysis. Subjects who have signed an IRB-approved informed consent form and who meet all of the inclusion criteria and none of the exclusion criteria will simultaneously have their Epogen dose reduced by 50% and initiate 300 mg vadadustat TIW. Subsequent dose modifications will occur in order to target a narrow hemoglobin range (10-11 g/dL). Patients will have their hemoglobin assessed every 2 weeks and will continue in the trial for up to 28 weeks.
Interventions
DRUGEpoetin alga (Epogen)/vadadustat
Phased transition from Epogen to three times weekly (TIW) oral vadadustat
Sponsors
Geoff Block
Akebia Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥18 years of age * Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed) * Currently receiving EPO (active administration, not on HOLD) * Less than or equal to 0.75 g/d difference between last 2 Hgb values prior to Screening, with neither Hgb \<9 g/dL * Average of last 2 Hgb between 9-11.4 g/dL (inclusive) prior to Screening * Central Screening Hgb 9-11.4 g/dL (inclusive) * Central Screening transferrin saturation greater than or equal to 20% * Central Screening serum ferritin greater than or equal to 100 ng/mL * 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 per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN) * Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease * EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer * Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide) * Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study * Documented unplanned absence from dialysis greater than or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments) * Pregnant at time of consent (per subject self-report)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20 | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients starting three times per week vadadustat (TIW-V) who do not demonstrate a drop in Hgb >0.75 g/dL at any point from baseline to week 20 | 20 weeks |
| Proportion of patients starting three times per week vadadustat (TIW-V) who achieve a mean Hgb in a range of 9-11.5 g/dL during weeks 20-24 | weeks 20-24 |
Contacts
CONTACTStephanie Brillhart
CONTACTMartha Block
Outcome results
None listed