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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deltanoid Pharmaceuticals
• Treatments: Calcitriol; Vitamin D

Criteria

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