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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01922843

Hyperparathyroidism, Secondary Kidney Failure, Chronic

COMPLETED PHASE2

Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

NCT00285467

Renal Osteodystrophy

COMPLETED NA

Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

NCT00110929

End Stage Renal Disease

COMPLETED PHASE2

Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

NCT00958451

Secondary Hyperparathyroidism Chronic Kidney Disease

COMPLETED PHASE4

Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease

NCT00781417

Kidney Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Hyperparathyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DP001

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

Group Type EXPERIMENTAL

DP001

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DP001

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No