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

Completed · Phase 2

Conditions studied: Secondary Hyperparathyroidism

In brief

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.

Key facts

Study ID

NCT01653379

Run by

Deltanoid Pharmaceuticals

People needed

42

Starts

2012-08-01

Expected to finish

2014-07-01

Last updated by the study team

2017-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Tustin, California, United States
• Study site — Denver, Colorado, United States
• Study site — St Louis, Missouri, United States
• Study site — Greenville, Texas, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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