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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2014

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.

Interventions

  • Drug: DP001 softgel capsules
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: DP001
    • DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks
  • Placebo Comparator: Placebo
    • Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Mean percentage change in serum iPTH
    • Time Frame: Baseline to 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deltanoid Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ravi Thadhani, MD, Study Chair, Massachusetts General Hospital

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