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: April 9, 2014
Last verified: April 2014

October 26, 2009
April 9, 2014
October 2009
November 2011   (final data collection date for primary outcome measure)
Glucose Area Under the Curve (AUC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Glucose AUC during a 2-hour oral glucose tolerance test
Change in glucose area under curve (AUC) following an oral glucose tolerance test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01003275 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
Metabolic Effects of Paricalcitol
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
  • 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: Paricalcitol followed by placebo
    Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
    Interventions:
    • Drug: Paricalcitol
    • Drug: Placebo
  • Active Comparator: Placebo followed by paricalcitol
    Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
    Interventions:
    • Drug: Paricalcitol
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01003275
35501-D
No
Ian deBoer, University of Washington
University of Washington
Abbott
Principal Investigator: Ian H de Boer, MD, MS University of Washington
University of Washington
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP