2MD-7H-2B: A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

Sponsor

Deltanoid Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01922843

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism, Secondary Kidney Failure, Chronic	Drug: DP001 softgel capsules Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DP001 DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks	Drug: DP001 softgel capsules Other Names: 2-methylene-19-nor-20S-1α,25-(OH)2D3 PF-00217763 2MD
Placebo Comparator: Placebo Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks	Drug: Placebo Other Names: Placebo soft gel capsules

Arm

Intervention/Treatment

Experimental: DP001

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

Drug: DP001 softgel capsules

Other Names:

2-methylene-19-nor-20S-1α,25-(OH)2D3

PF-00217763

2MD

Placebo Comparator: Placebo

Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks

Drug: Placebo

Other Names:

Placebo soft gel capsules

Outcome Measures

Primary Outcome Measures

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

Mean percentage change in serum iPTH [Baseline to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Tucson	Arizona	United States
3	Washington, D.C.	District of Columbia	United States
4	Evanston	Illinois	United States
5	Saint Louis	Missouri	United States
6	Las Vegas	Nevada	United States
7	Great Neck	New York	United States
8	Ridgewood	New York	United States
9	Charlotte	North Carolina	United States
10	Cincinnati	Ohio	United States
11	Nashville	Tennessee	United States
12	Fort Worth	Texas	United States
13	Grand Prairie	Texas	United States
14	San Antonio	Texas	United States