Back to resultsA Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis (2MD-7H-2B)
Primary Purpose
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DP001 softgel capsules
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism, Secondary focused on measuring Hemodialysis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DP001
Placebo
Arm Description
DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks
Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks
Outcomes
Primary Outcome Measures
The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level
Secondary Outcome Measures
Mean percentage change in serum iPTH
Full Information
NCT ID
NCT01922843
First Posted
August 12, 2013
Last Updated
August 15, 2017
Sponsor
Deltanoid Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01922843
Brief Title
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
Acronym
2MD-7H-2B
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deltanoid Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
Keywords
Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DP001
Arm Type
Experimental
Arm Description
DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks
Intervention Type
Drug
Intervention Name(s)
DP001 softgel capsules
Other Intervention Name(s)
2-methylene-19-nor-20S-1α,25-(OH)2D3, PF-00217763, 2MD
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo soft gel capsules
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Mean percentage change in serum iPTH
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Thadhani, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Washington, D.C.
State/Province
District of Columbia
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Great Neck
State/Province
New York
Country
United States
City
Ridgewood
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Grand Prairie
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27880946
Citation
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.
Results Reference
derived
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A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
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