Table 2.

Final eligibility criteria

INNO2VATE incident trial	INNO2VATE prevalent trial
NCT02865850 (n = 369)	NCT02892149 (n = 3554)
Adults (≥18 years) who initiated chronic maintenance dialysis (either peritoneal or haemodialysis) for end-stage kidney disease within 16 weeks prior to screening	Adults (≥18 years) receiving chronic maintenance dialysis (either peritoneal or haemodialysis) for end-stage kidney disease for at least 12 weeks prior to screening
Ferritin ≥100 ng/mL and TSAT ≥20% Folate and vitamin B12 measurements greater than or equal to the lower limit of normal at screening Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
Hb eligibility
Hb 8–11 g/dL	USA: Hb 8–11 g/dL
	Non-USA: Hb 9–12 g/dL
ESA treatment
Limited prior exposure to ESA therapy (see text for details) Cannot have met the following criteria for ESA resistance within 8 weeks prior to or during screening: epoetin >7700 U/dose three times per week or >23 000 U/week, darbepoetin alfa >100 μg/week or methoxy polyethylene glycol-epoetin beta >100 μg every other week or >200 μg every month	Currently maintained on ESA therapy, with a dose received within 6 weeks prior to or during screening
RBC transfusions
No RBC transfusions within 8 weeks prior to randomization
Exclusion of patients with any of the following:
Anaemia due to a cause other than CKD or patients with active bleeding or recent blood loss
History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, haematologic malignancy, myeloma, haemolytic anaemia, thalassemia or pure red cell aplasia
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase, alanine aminotransferase/serum glutamic pyruvic transaminase or total bilirubin >2.0 times the upper limit of normal during screening; patients with a history of Gilbert’s syndrome are not excluded
Uncontrolled hypertension (defined as confirmed predialysis systolic BP >190 mmHg or diastolic BP >110 mmHg at rest) at or during screening
Severe heart failure (HF) at or during screening (New York Heart Association Class IV)
Acute coronary syndrome (hospitalization for unstable angina or MI), 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 HF or stroke within 12 weeks prior to or during screening
History of active malignancy within 2 years prior to or during screening, except for treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin or cervical carcinoma in situ
History of DVT or PE within 12 weeks prior to randomization
History of haemosiderosis or haemochromatosis
History of prior organ transplantation or scheduled organ transplant (patients on the kidney transplant wait-list or with a history of failed kidney transplant are not excluded) or prior haematopoietic stem cell or bone marrow transplant (corneal transplants and stem cell therapy for knee arthritis are not excluded)
Hypersensitivity to vadadustat, darbepoetin alfa 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 or during screening
Previous participation in this study or previous participation in a study with HIF-PHI other than vadadustat
Females who are pregnant, breastfeeding or are of childbearing potential who are unable or unwilling to use an acceptable method of contraception
Non-vasectomized male patients who are unable or unwilling to use an acceptable method of contraception
Any other reason, which in the opinion of the investigator, would make the patient not suitable for participation in the study

BP, blood pressure; DVT, deep vein thrombosis; PE, pulmonary embolism.