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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperparathyroidism, Secondary, Kidney Failure, Chronic

In brief

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.

Key facts

Study ID

NCT01922843

Run by

Deltanoid Pharmaceuticals

People needed

62

Starts

2013-09-01

Expected to finish

2014-06-01

Last updated by the study team

2017-08-18

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Evanston, Illinois, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Great Neck, New York, United States
• Study site — Ridgewood, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — Grand Prairie, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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