A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
NCT ID: NCT01922843
Last Updated: 2017-08-18
Study Results
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Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2013-09-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DP001
DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks
DP001 softgel capsules
Placebo
Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks
Placebo
Interventions
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DP001 softgel capsules
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Deltanoid Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Ravi Thadhani, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
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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
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Grand Prairie, Texas, United States
San Antonio, Texas, United States
Countries
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References
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Thadhani R, Zella JB, Knutson DC, Blaser WJ, Plum LA, Clagett-Dame M, Buck RD, DeLuca HF. 2MD (DP001), a Single Agent in the Management of Hemodialysis Patients: A Randomized Trial. Am J Nephrol. 2017;45(1):40-48. doi: 10.1159/000452680. Epub 2016 Nov 24.
Other Identifiers
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2MD-7H-2B
Identifier Type: -
Identifier Source: org_study_id
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