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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01653379
First received: July 25, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Secondary Hyperparathyroidism
Drug: DP001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Deltanoid Pharmaceuticals:

Primary Outcome Measures:
  • Change in intact parathyroid hormone levels in blood [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood levels of DP001 [ Time Frame: Multiple time points following single dose and 4 weeks of dosing ] [ Designated as safety issue: No ]
    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


Enrollment: 42
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
St. 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:
No publications provided

Responsible Party: Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01653379     History of Changes
Other Study ID Numbers: 2MD-7H-2A
Study First Received: July 25, 2012
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014