Metabolic Effects of Paricalcitol

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Paricalcitol; Drug: Placebo

• Registration Number: NCT01003275
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-06-18
• Results First Submitted QC: 2013-09-26
• Results First Posted: 2013-09-27
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Paricalcitol followed by placebo	Placebo	Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
Placebo followed by paricalcitol	Placebo	Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
Paricalcitol followed by placebo	Paricalcitol	Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
Placebo followed by paricalcitol	Paricalcitol	Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Glucose Area Under the Curve (AUC)	8 weeks	Glucose AUC during a 2-hour oral glucose tolerance test

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States