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.
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
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)
Single group
Epoetin alga (Epogen)/vadadustat
DrugPhased transition from Epogen to three times weekly (TIW) oral vadadustat
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20
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
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
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
