## Protocol Section
### Identification Module
**NCT ID:** NCT01653379

**Brief Title:** A Phase 2A Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism

**Official Title:** A Phase 2A, Open-label, Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

#### Organization Study ID Info
**ID:** 2MD-7H-2A
#### Organization
**Class:** INDUSTRY
**Full Name:** Deltanoid Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2014-07

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2017-08-16

**Type:** ACTUAL

**Disp First Submit Date:** 2017-08-14
**Disp First Submit QC Date:** 2017-08-14

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-16

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-07

**Type:** ACTUAL

#### Start Date
**Date:** 2012-08

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2012-07-31
**Type:** ESTIMATED
**Study First Submit Date:** 2012-07-25
**Study First Submit QC Date:** 2012-07-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Deltanoid Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to identify an appropriate starting dose of DP001 to be used in subsequent studies in this population and for evaluation of pharmacokinetics of DP001 in ESRD patients.

**Detailed Description:** Vitamin D hormone or analogs, when bound to the vitamin D receptor, suppress PTH synthesis by binding to a negative regulatory element in the promoter of the PTH gene, and have been used successfully in the clinic to reduce elevated PTH levels in dialysis patients and other CKD patients. DP001 is a highly potent vitamin D compound.

In two clinical trials testing DP001 in postmenopausal women, oral DP001 reduced PTH levels in a dose-dependent manner, with a dose of 220 ng lowering PTH by at least 30% in a majority of patients following one or six months of daily dosing.

This study is an open-label, dose-ranging study of DP001 in ESRD patients with secondary hyperparathyroidism. Cohorts of up to 6 patients will be enrolled and administered oral DP001 at 110 ng three times per week for four weeks. Laboratory data from each cohort will be assessed and used to determine a dose for the next cohort. Up to 5 dose-ranging cohorts will be studied, with the goal of identifying an appropriate dose for a randomized, placebo-controlled study of oral DP001 for 12 weeks. The data will also be used to select an appropriate dose for an additional cohort of 12 open-label patients in the current study in which the pharmacokinetics of DP001 following a single dose and after repeated doses will be studied.

### Conditions Module

**Conditions:**

- Secondary Hyperparathyroidism

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 42

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks

**Intervention Names:**

- Drug: DP001

**Label:** DP001

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- DP001

**Description:** DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks

**Name:** DP001

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in intact parathyroid hormone levels in blood

**Time Frame:** Baseline and 4 weeks

#### Secondary Outcomes

**Description:** 1, 2, 4, 8, 24, and 48 hours following a single dose; 1, 2, 4, 8, 24, 48, 72, and 96 hours following multiple doses

**Measure:** Blood levels of DP001

**Time Frame:** Multiple time points following single dose and 4 weeks of dosing

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months
* Plasma intact PTH value \>/= 300 pg/mL

Exclusion Criteria:

* Currently taking drugs affecting vitamin D metabolism
* History of symptomatic ventricular dysrhythmias, congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, or coronary artery bypass grafting
* Active malignancy
* Clinically significant liver disease
* Active infections

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tucson

**Country:** United States

**State:** Arizona

**Location 2:**

**City:** Tustin

**Country:** United States

**State:** California

**Location 3:**

**City:** Denver

**Country:** United States

**State:** Colorado

**Location 4:**

**City:** Saint Louis

**Country:** United States

**State:** Missouri

**Location 5:**

**City:** Greenville

**Country:** United States

**State:** Texas

**Location 6:**

**City:** Madison

**Country:** United States

**State:** Wisconsin

#### Overall Officials

**Official 1:**

**Affiliation:** Massachusetts General Hospital

**Name:** Ravi Thadhani, MD

**Role:** STUDY_CHAIR

### References Module

#### See Also Links

**Label:** To obtain contact information for a study center near you, click here:

**URL:** http://deltanoid.com/contact.php

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010279

- Term: Parathyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Secondary

- ID: M10012

- Name: Hyperparathyroidism

- Relevance: HIGH

- As Found: Hyperparathyroidism

- ID: M10013

- Name: Hyperparathyroidism, Secondary

- Relevance: HIGH

- As Found: Secondary Hyperparathyroidism

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M13192

- Name: Parathyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000006961

- Term: Hyperparathyroidism

- ID: D000006962

- Term: Hyperparathyroidism, Secondary

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
