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

Kidney Failure, Chronic Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922843
• Other study ID #: 2MD-7H-2B
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2013
• Last updated: August 15, 2017
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2017
• Source: Deltanoid Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Renal Insufficiency

Intervention

Drug:
• DP001 softgel capsules

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deltanoid Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean percentage change in serum iPTH		Baseline to 12 weeks