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A Phase 2B, Double-blind, Randomized, Placebo-controlled, Proof-of-concept Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
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.
This is a randomized, double-blind, placebo-controlled study of the vitamin D analog 2-methylene-19-nor-20S-1α,25-dihydroxyvitamin D3 (DP001) in patients with end-stage renal disease (ESRD). The effect of 12 weeks of oral administration of DP001 on serum parathyroid hormone (PTH) levels will be evaluated in ESRD patients who have secondary hyperparathyroidism.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Phoenix, Arizona, United States
Tucson, Arizona, United States
Washington D.C., District of Columbia, United States
Evanston, Illinois, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Great Neck, New York, United States
Ridgewood, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Start Date
September 1, 2013
Primary Completion Date
May 1, 2014
Completion Date
June 1, 2014
Last Updated
August 18, 2017
62
ACTUAL participants
DP001 softgel capsules
DRUG
Placebo
DRUG
Lead Sponsor
Deltanoid Pharmaceuticals
NCT06314503
NCT06438445
Data Source & Attribution
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