A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures