We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01003275
Previous Study | Return to List | Next Study

Metabolic Effects of Paricalcitol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01003275
First Posted: October 28, 2009
Last Update Posted: April 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Ian deBoer, University of Washington
  Purpose
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).

Condition Intervention Phase
Chronic Kidney Disease Drug: Paricalcitol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Oral Paricalcitol on Glucose Tolerance, Immune Cell Function, and Oxidative Stress in Stage 3-4 Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Ian deBoer, University of Washington:

Primary Outcome Measures:
  • Glucose Area Under the Curve (AUC) [ Time Frame: 8 weeks ]
    Glucose AUC during a 2-hour oral glucose tolerance test


Enrollment: 22
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Zemplar
Drug: Placebo
Two soft gels by mouth daily for 8 weeks

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003275


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Abbott
Investigators
Principal Investigator: Ian H de Boer, MD, MS University of Washington
  More Information

Publications:
Responsible Party: Ian deBoer, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01003275     History of Changes
Other Study ID Numbers: 35501-D
First Submitted: October 26, 2009
First Posted: October 28, 2009
Results First Submitted: June 18, 2013
Results First Posted: September 27, 2013
Last Update Posted: April 28, 2014
Last Verified: April 2014

Keywords provided by Ian deBoer, University of Washington:
Chronic kidney disease
Vitamin D
Paricalcitol
Placebo
Kidney
Renal
Oxidative Stress
Immune cell function
Glucose
Glucose tolerance

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents