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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hyperparathyroidism, Secondary, Kidney Failure, Chronic

Intervention / Treatment
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* Drug: DP001 softgel capsules
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DP001<br>DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks | Drug: DP001 softgel capsules<br> <br> * Other names: 2MD;|
| Placebo Comparator: Placebo<br>Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks | Drug: Placebo<br> <br> * Other names: Placebo soft gel capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage change in serum iPTH |  | Baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis