Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease

Korábbi kezelés

• RBC transfusion, intravenous iron, or ESA use within 12 weeks prior to screening
• Receiving an SGLT2 inhibitor on a dose that has not been stable for at least 12 weeks prior to screening.
• Has a concurrent disease or condition or physical, psychological, mental, and/or social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study.

Más betegség

• Anemia due to a cause other than CKD, presence of active bleeding, or recent significant blood loss
• Any hemoglobinopathy, bone marrow pathology or hematological malignancy, including, but not limited to sickle cell disease, thalassemia, myelodysplastic syndrome, bone marrow fibrosis, red cell aplasia
• Known history of hemochromatosis or other iron-overload disorder, or ferritin \>700 ng/mL
• Has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.

Egyéb

• Pregnant or breastfeeding.
• Is unable or unwilling to comply with protocol-specified sun protection and contraception requirements.

• Between 18 and 75 years of age
• Body mass index (BMI) between 18 and 35 kg/m2
• Estimated GFR ≥15 and \<60 mL/min/1.73 m2
• CKD for at least 3 months
• Not currently receiving dialysis and not expected to start dialysis within 3 months of screening.
• Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL
• Transferrin saturation (TSAT) ≤20%
• Not folate or vitamin B12 deficient
• ALT and AST ≤1.5 x ULN and TBL ≤1.5 x ULN