NCT01653379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

July 25, 2012

Last Update Submit

August 14, 2017

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Change in intact parathyroid hormone levels in blood

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Blood levels of DP001

    Multiple time points following single dose and 4 weeks of dosing

Study Arms (1)

DP001

EXPERIMENTAL

DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks

Drug: DP001

Interventions

DP001DRUG

DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks

DP001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Tustin, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Greenville, Texas, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Ravi Thadhani, MD

    Massachusetts General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 31, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

US(6)