A Phase 2A Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to identify an appropriate starting dose of DP001 to be used in subsequent studies in this population and for evaluation of pharmacokinetics of DP001 in ESRD patients.

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

Details

• Lead Sponsor: Deltanoid Pharmaceuticals
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

• Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months

• Plasma intact PTH value >/= 300 pg/mL

Exclusion Criteria:

• Currently taking drugs affecting vitamin D metabolism

• History of symptomatic ventricular dysrhythmias, congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, or coronary artery bypass grafting

• Active malignancy

• Clinically significant liver disease

• Active infections