Clinical trial NCT01922843: A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Keywords: Hemodialysis
Lead sponsor: Deltanoid Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level
timeFrame: 12 weeks, with weekly iPTH measurements
Secondary outcomes:
measure: Mean percentage change in serum iPTH
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Washington, D.C.
country: United States
state: District of Columbia
city: Evanston
country: United States
state: Illinois
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Great Neck
country: United States
state: New York
city: Ridgewood
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Grand Prairie
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Ravi Thadhani, MD
role: STUDY_CHAIR
References:
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.