Clareo Health | Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
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Lead
Kyntra Bio
With
AstraZeneca
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Receiving chronic dialysis for end stage renal disease (ESRD)
Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunneled catheter
Screening hemoglobin criteria (based on central lab value; measured within 10 days prior to initiating Roxadustat treatment: Participants converting from CERA: screening heamoglobin was between 9.0 to 12.0 g/dL; Participants initiating anemia treatment: \<10.0 g/dL
Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN at screening and prior to initiating roxadustat treatment.
Body weight between 45.0 to 160.0 kg
You may not be if
Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
Known history of myelodysplastic syndrome or multiple myeloma
Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
Active or chronic gastrointestinal bleeding
Treated with iron-chelating agents within 4 weeks prior to enrollment
History of New York Heart Association (NYHA) Class III or IV congestive heart failure
History of myocardial infarction (MI), acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
Uncontrolled hypertension, in the opinion of the Investigator
Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment
History of malignancy, except for cancers determined to be cured or in remission for ≥2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
