Clinical trial NCT01003275: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
Vitamin D
Paricalcitol
Placebo
Kidney
Renal
Oxidative Stress
Immune cell function
Glucose
Glucose tolerance
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2009-10-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glucose Area Under the Curve (AUC)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ian H de Boer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.