A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

Inclusion Criteria: * Men and non-pregnant women ≥18 years of age * Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months prior to Screening Phase * Patient is currently being treated with pharmaceutical vitamin D for the treatment of secondary hyperparathyroidism * Serum iPTH value ≤500 pg/mL at first screening visit * Total serum calcium (corrected for albumin) ≤10.5 mg/dL at first screening visit * Serum phosphorus ≤7.0 mg/dL at first screening visit Exclusion Criteria: * Currently taking any of the following: drugs affecting vitamin D metabolism, digitalis, glucocorticoids, cyclosporine or other immunosuppressants, aluminum-based phosphate binders * A daily intake \>4000 IU vitamin D (D3 + D2) * Any investigational drug use within 10 half-lives of the drug (or within the previous 30 days if the half-life of the drug is unknown) * History of any of the following: ventricular dysrhythmias, severe congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, coronary artery bypass grafting, multiple myeloma, calciphylaxis, active malignancy, end-stage liver disease, active infections, clinically significant renal/urinary tract stones, sarcoidosis, tuberculosis, parathyroidectomy * Major surgery within the past 3 months