Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Europe B.V.
With
Kyntra Bio
This study consisted of three study periods as follows:
* Screening Period: up to 6 weeks
* Treatment Period: a minimum of 52 weeks up to a maximum of 104 weeks
* Follow-up Period: 4 weeks
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Main Inclusion:
Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization.
Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization).
Mean of the participant's three most recent Hb values, as measured by central laboratory, during the Screening Period.
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
You may not be if
Main Exclusion:
Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization.
Participant has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD).
Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization.
Participant has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation.
