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NCT07565701Not yet recruitingPhase 3

Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
100 (estimated)
First submitted
27 Apr 2026
Start date
1 Apr 2026
Primary completion date
30 Apr 2027
Lead sponsor
Geoff Block
NCT number
NCT07565701

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 100
  • From 1 Apr 2026 to the primary completion date, 30 Apr 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide)
  • Documented unplanned absence from dialysis greater than or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments)

Other illness

  • 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

Lab values

  • Contraindication to receive vadadustat per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN)

Other

  • 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
  • Pregnant at time of consent (per subject self-report)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.