NCT01922843

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

14 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

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

August 12, 2013

Last Update Submit

August 15, 2017

Conditions

Hyperparathyroidism, SecondaryKidney Failure, Chronic

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level

    12 weeks, with weekly iPTH measurements

Secondary Outcomes (1)

  • Mean percentage change in serum iPTH

    Baseline to 12 weeks

Study Arms (2)

DP001

EXPERIMENTAL

DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks

Drug: DP001 softgel capsules

Placebo

PLACEBO COMPARATOR

Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks

Drug: Placebo

Interventions

DP001 softgel capsulesDRUG
Also known as: 2-methylene-19-nor-20S-1α,25-(OH)2D3, PF-00217763, 2MD
DP001
PlaceboDRUG
Also known as: Placebo soft gel capsules
Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Great Neck, New York, United States

Location

Unknown Facility

Ridgewood, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Grand Prairie, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Publications (1)

  • Thadhani R, Zella JB, Knutson DC, Blaser WJ, Plum LA, Clagett-Dame M, Buck RD, DeLuca HF. 2MD (DP001), a Single Agent in the Management of Hemodialysis Patients: A Randomized Trial. Am J Nephrol. 2017;45(1):40-48. doi: 10.1159/000452680. Epub 2016 Nov 24.

    PMID: 27880946DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryKidney Failure, Chronic

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ravi Thadhani, MD

    Massachusetts General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

US(14)