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Brief Title: A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
Official Title: 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
Study ID: NCT01922843
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
, Saint 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
, Nashville, Tennessee, United States
, Fort Worth, Texas, United States
, Grand Prairie, Texas, United States
, San Antonio, Texas, United States
Name: Ravi Thadhani, MD
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR