Metabolic Effects of Paricalcitol

April 9, 2014 updated by: Ian deBoer, University of Washington

Effects of Oral Paricalcitol on Glucose Tolerance, Immune Cell Function, and Oxidative Stress in Stage 3-4 Chronic Kidney Disease

The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.

This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Estimated glomerular filtration rate of 15-59 mL/min/1.73m2
  • Fasting glucose 100-125 mg/dL
  • 18 years and older

Exclusion Criteria:

  • Diagnosed with diabetes mellitus
  • Use of diabetes medications (insulin or oral hypoglycemics)
  • Prior dialysis or transplantation
  • Planning to leave the area within 6 months
  • Participation in another clinical trial within 30 days
  • Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
  • Serum calcium more than 10.2 mg/dL
  • Pregnancy or breast-feeding
  • Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or Ergocalciferol
  • Incontinent of urine
  • Cancer (other than skin cancer) within 5 years
  • Tuberculosis
  • Sarcoidosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Paricalcitol followed by placebo
Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
Drug: Paricalcitol
Two 1 mcg soft gels by mouth daily for 8 weeks
Other Names:
  • Zemplar
Drug: Placebo
Two soft gels by mouth daily for 8 weeks
ACTIVE_COMPARATOR: Placebo followed by paricalcitol
Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
Drug: Paricalcitol
Two 1 mcg soft gels by mouth daily for 8 weeks
Other Names:
  • Zemplar
Drug: Placebo
Two soft gels by mouth daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Area Under the Curve (AUC)
Time Frame: 8 weeks
Glucose AUC during a 2-hour oral glucose tolerance test
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (ESTIMATE)

October 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35501-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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