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

August 15, 2017 updated by: Deltanoid Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Placebo
Other Names:
  • Placebo soft gel capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks, with weekly iPTH measurements

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean percentage change in serum iPTH
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deltanoid Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (ESTIMATE)

August 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2MD-7H-2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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