Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

Completed · Phase 2

Conditions studied: Anemia, Dialysis-dependent Chronic Kidney Disease

In brief

This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.

Key facts

Study ID: NCT03799627
Run by: Akebia Therapeutics
People needed: 175
Starts: 2019-01-31
Expected to finish: 2020-07-15
Last updated by the study team: 2022-09-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥18 years of age, providing informed consent
Receiving chronic, outpatient in-center hemodialysis (TIW) for end-stage renal disease for at least 12 weeks prior to Screening
Maintained on intravenous Epoetin Alfa therapy for 8 weeks prior to and including Screening through Screening Visit 2 (SV2)
Eligibility in the Main study and erythropoiesis-stimulating agent (ESA) hyporesponder parallel study is based on the following mean weekly Epoetin Alfa doses:
Main study: Mean weekly Epoetin Alfa dose <300 Units per kilogram per week (U/kg/week) for 8 weeks prior to SV2;
ESA hyporesponder parallel study: Mean weekly Epoetin Alfa dose ≥300 U/kg/week for 8 weeks prior to SV2
Two Hb values measured by the central laboratory at least 4 days apart between Screening Visit 1 (SV1) and SV2 as indicated:.
Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive;
ESA hyporesponder parallel study: 2 Hb values between 8.0 and 10.0 grams per deciliter (g/dL), inclusive
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
Folate and vitamin B12 measurements ≥ lower limit of normal during Screening
Hemodialysis adequacy as indicated by single-pool Kt/Vurea ≥1.2 using the most recent historical measurement within 8 weeks prior to or during Screening
Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

You may not qualify if…

Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia)
Active bleeding or recent blood loss within 8 weeks prior to randomization
Red blood cell (RBC) transfusion within 8 weeks prior to randomization
Anticipated to discontinue hemodialysis during the study
Judged by the Investigator that the participant is likely to need rescue therapy (ESA administration or RBC transfusion) immediately after enrollment in the study
History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver)
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), or total bilirubin >1.5 x upper limit of normal (ULN) during Screening. Participants with a history of Gilbert's syndrome are not excluded.
Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of Epoetin Alfa
Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening
History of new or recurrent malignancy within 2 years prior to and during Screening or currently receiving treatment or suppressive therapy for cancer. Participants with treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ are not excluded.
History of deep vein thrombosis or pulmonary embolism within 12 weeks prior to or during Screening
History of hemosiderosis or hemochromatosis
History of prior organ transplantation (participants with a history of failed kidney transplant or corneal transplants are not excluded)
Scheduled organ transplant from a living donor and participants on the kidney transplant wait-list who are expected to receive a transplant within 6 months
History of a prior hematopoietic stem cell or bone marrow transplant (stem cell therapy for knee arthritis is not excluded)
Known hypersensitivity to Vadadustat, Epoetin Alfa, or any of their excipients
Any prior use of a hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitor or any use of an investigational medication within 30 days or 5 half-lives of the investigational medication (whichever is longer), prior to randomization
For female participants of non-childbearing potential:
inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 1 month prior to Screening;
not considered post-menopausal (no menses for >1 year with follicle stimulating hormone >40 U/Liter at Screening)
For female participants of childbearing potential:
lack of confirmation of the use of acceptable forms of contraception* for a minimum of one complete menstrual cycle prior to Screening;
positive serum pregnancy test at SV2;
unwilling to use two acceptable forms of contraception* (at least one of which must be a barrier method) starting Baseline/Day 1, throughout the Treatment Period and for 30 days after the final study drug administration
Breastfeeding during Screening or throughout the Treatment Period and for 30 days after the final study drug administration

Where it is running

Research Site — Fresno, California, United States
Research Site — Granada Hills, California, United States
Research Site — Los Angeles, California, United States
Research Site — Northridge, California, United States
Research Site — Riverside, California, United States
Research Site #1 — San Dimas, California, United States
Research Site #2 — San Dimas, California, United States
Research Site — San Gabriel, California, United States
Research Site — Tarzana, California, United States
Research Site — Vacaville, California, United States
Research Site — Victorville, California, United States
Research Site — Denver, Colorado, United States
Research Site — Bridgeport, Connecticut, United States
Research Site — Hartford, Connecticut, United States
Research Site — Coral Gables, Florida, United States
Research Site — Hollywood, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Winter Park, Florida, United States
Research Site — Augusta, Georgia, United States
Research Site — Statesboro, Georgia, United States
Research Site — Roseville, Michigan, United States

Full record on ClinicalTrials.gov

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