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A Phase 2A Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT01653379
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to identify an appropriate starting dose of DP001 to be used in subsequent studies in this population and for evaluation of pharmacokinetics of DP001 in ESRD patients.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: DP001 Phase 2

Detailed Description:

Vitamin D hormone or analogs, when bound to the vitamin D receptor, suppress PTH synthesis by binding to a negative regulatory element in the promoter of the PTH gene, and have been used successfully in the clinic to reduce elevated PTH levels in dialysis patients and other CKD patients. DP001 is a highly potent vitamin D compound.

In two clinical trials testing DP001 in postmenopausal women, oral DP001 reduced PTH levels in a dose-dependent manner, with a dose of 220 ng lowering PTH by at least 30% in a majority of patients following one or six months of daily dosing.

This study is an open-label, dose-ranging study of DP001 in ESRD patients with secondary hyperparathyroidism. Cohorts of up to 6 patients will be enrolled and administered oral DP001 at 110 ng three times per week for four weeks. Laboratory data from each cohort will be assessed and used to determine a dose for the next cohort. Up to 5 dose-ranging cohorts will be studied, with the goal of identifying an appropriate dose for a randomized, placebo-controlled study of oral DP001 for 12 weeks. The data will also be used to select an appropriate dose for an additional cohort of 12 open-label patients in the current study in which the pharmacokinetics of DP001 following a single dose and after repeated doses will be studied.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A, Open-label, Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
Study Start Date : August 2012
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: DP001
DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks
Drug: DP001
DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks


Outcome Measures

Primary Outcome Measures :
  1. Change in intact parathyroid hormone levels in blood [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :
  1. Blood levels of DP001 [ Time Frame: Multiple time points following single dose and 4 weeks of dosing ]
    1, 2, 4, 8, 24, and 48 hours following a single dose; 1, 2, 4, 8, 24, 48, 72, and 96 hours following multiple doses


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months
  • Plasma intact PTH value >/= 300 pg/mL

Exclusion Criteria:

  • Currently taking drugs affecting vitamin D metabolism
  • History of symptomatic ventricular dysrhythmias, congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, or coronary artery bypass grafting
  • Active malignancy
  • Clinically significant liver disease
  • Active infections
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653379


Locations
United States, Arizona
Tucson, Arizona, United States
United States, California
Tustin, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Texas
Greenville, Texas, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Deltanoid Pharmaceuticals
Investigators
Study Chair: Ravi Thadhani, MD Massachusetts General Hospital
More Information

Additional Information:
Responsible Party: Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01653379     History of Changes
Other Study ID Numbers: 2MD-7H-2A
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017

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