Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera ) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    450
  • sponsor
    Akebia Therapeutics
Updated on 24 September 2021

Summary

This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera) for the maintenance treatment of anemia in hemodialysis participants.

Description

Following randomization, there will be 2 periods during the study:

  • Conversion and Maintenance Period (Weeks 0 to 52): conversion to vadadustat TIW or to remain on Mircera (Weeks 0 to 20). There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).
  • Safety Follow-up Period (Early Termination [ET] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment [EOT] +4 weeks) either in person or via telephone.

Details
Condition Anemia Associated With Chronic Kidney Disease
Treatment vadadustat, Mircera®
Clinical Study IdentifierNCT04707768
SponsorAkebia Therapeutics
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age
Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)
Currently maintained on Mircera with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)
Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2
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

Exclusion Criteria

Anemia due to a cause other than chronic kidney disease (CKD) (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia)
Clinically meaningful bleeding event in opinion of Investigator within 8 weeks prior to Baseline
Red blood cell (RBC) transfusion within 8 weeks prior to Baseline
Having received any doses of darbepoetin alfa (Aranesp) within 4 weeks prior to Baseline
Having received any doses of epoetin alfa (Epogen) within 1 week prior to Baseline
Anticipated to discontinue hemodialysis during the study
Judged by the Investigator that the participant is likely to need rescue therapy (erythropoiesis-stimulating agent [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 >2 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 an ESA
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, active 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 treated 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, Mircera, or any of their excipients
Use of an investigational medication or participation in an investigational study within 30 days or 5 half-lives of the investigational medication (whichever is longer), prior to Screening (participants may participate in another concurrent study only if that study is a non-interventional, observational investigation)
Current exposure to any hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor or prior exposure to vadadustat
Participants with bilateral native nephrectomy
Noncompliance with dialysis session attendance defined as missing more than 1 dialysis session within 8 weeks prior to Baseline
Active Severe Acute Respiratory Syndrome-Related Coronavirus (SARS CoV-2) during Screening
Females who are pregnant or breastfeeding during Screening or are planning to become pregnant and breastfeeding during the study period, and for 30 days after the final study drug administration
Women of childbearing potential who are unable or unwilling to use 2 acceptable methods of contraception starting at Screening, throughout the study period and for 45 days after the final study drug administration. Acceptable methods of contraception include (a.) established use of oral, injected, or implanted hormonal methods of contraception; (b.) placement of an intrauterine device or intrauterine system; (c.) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Female participants of childbearing potential who plan to donate ova during the study, and for 30 days after the last dose of study drug
Non-vasectomized male participants who are unable or unwilling to use an acceptable method of contraception from time of first dose of study drug until 30 days after the last dose of the study drug
Male participants who plan to donate sperm during the study and for at least 30 days after the last dose of study drug
Any other reason, which in the opinion of the Investigator, would make the participant not suitable for participation in the study
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