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Metabolic Effects of Paricalcitol

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paricalcitol
Placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Vitamin D, Paricalcitol, Placebo, Kidney, Renal, Oxidative Stress, Immune cell function, Glucose, Glucose tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paricalcitol followed by placebo

Placebo followed by paricalcitol

Arm Description

Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.

Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.

Outcomes

Primary Outcome Measures

Glucose Area Under the Curve (AUC)
Glucose AUC during a 2-hour oral glucose tolerance test

Secondary Outcome Measures

Full Information

First Posted
October 26, 2009
Last Updated
April 9, 2014
Sponsor
University of Washington
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01003275
Brief Title
Metabolic Effects of Paricalcitol
Official Title
Effects of Oral Paricalcitol on Glucose Tolerance, Immune Cell Function, and Oxidative Stress in Stage 3-4 Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic kidney disease, Vitamin D, Paricalcitol, Placebo, Kidney, Renal, Oxidative Stress, Immune cell function, Glucose, Glucose tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol followed by placebo
Arm Type
Active Comparator
Arm Description
Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
Arm Title
Placebo followed by paricalcitol
Arm Type
Active Comparator
Arm Description
Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
Zemplar
Intervention Description
Two 1 mcg soft gels by mouth daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two soft gels by mouth daily for 8 weeks
Primary Outcome Measure Information:
Title
Glucose Area Under the Curve (AUC)
Description
Glucose AUC during a 2-hour oral glucose tolerance test
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian H de Boer, MD, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22913981
Citation
de Boer IH, Sachs M, Hoofnagle AN, Utzschneider KM, Kahn SE, Kestenbaum B, Himmelfarb J. Paricalcitol does not improve glucose metabolism in patients with stage 3-4 chronic kidney disease. Kidney Int. 2013 Feb;83(2):323-30. doi: 10.1038/ki.2012.311. Epub 2012 Aug 22.
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Metabolic Effects of Paricalcitol

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