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A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis (2MD-7H-2B)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01922843
First received: August 12, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Drug: DP001 softgel capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Deltanoid Pharmaceuticals:

Primary Outcome Measures:
  • The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level [ Time Frame: 12 weeks, with weekly iPTH measurements ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean percentage change in serum iPTH [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: September 2013
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DP001
DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks
Drug: DP001 softgel capsules
Other Names:
  • 2-methylene-19-nor-20S-1α,25-(OH)2D3
  • PF-00217763
  • 2MD
Placebo Comparator: Placebo
Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922843

Locations
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Illinois
Evanston, Illinois, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Great Neck, New York, United States
Ridgewood, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Fort Worth, Texas, United States
Grand Prairie, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Deltanoid Pharmaceuticals
Investigators
Study Chair: Ravi Thadhani, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01922843     History of Changes
Other Study ID Numbers: 2MD-7H-2B
Study First Received: August 12, 2013
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Deltanoid Pharmaceuticals:
Hemodialysis

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Neoplasm Metastasis
Renal Insufficiency
Endocrine System Diseases
Kidney Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
Renal Insufficiency, Chronic
Urologic Diseases
Vitamin D
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on November 27, 2014