Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

Exclusion criteria

• ✕. Scheduled kidney transplant or parathyroidectomy.
• ✕. History (prior 2 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus
• ✕. Receipt of bisphosphonate therapy or other bone modifying treatment (eg, denosumab) within 6 months prior to enrollment.
• ✕. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
• ✕. History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely.
• ✕. Known or suspected hypersensitivity to any of the constituents of the study drugs.
• ✕. Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.