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Metabolic Effects of Paricalcitol

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ian deBoer, University of Washington
ClinicalTrials.gov Identifier:
NCT01003275
First received: October 26, 2009
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in glucose area under curve (AUC) following an oral glucose tolerance test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio of incremental AUC for C-peptide to incremental AUC for glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean of fasting insulin measurements [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Cytokine expression profiles of T-cells and monocytes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Serum cytokine profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Urine cytokine profile [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Urine F2-isoprostane excretion [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ian deBoer, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01003275     History of Changes
Other Study ID Numbers: 35501-D
Study First Received: October 26, 2009
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Ergocalciferols
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013