Metabolic Effects of Paricalcitol

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Oral Paricalcitol on Glucose Tolerance, Immune Cell Function, and Oxidative Stress in Stage 3-4 Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Paricalcitol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paricalcitol followed by placebo<br>Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. | Drug: Paricalcitol<br>* Two 1 mcg soft gels by mouth daily for 8 weeks<br>* Other names: Zemplar;Drug: Placebo<br>* Two soft gels by mouth daily for 8 weeks<br>|
| Active Comparator: Placebo followed by paricalcitol<br>Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. | Drug: Paricalcitol<br>* Two 1 mcg soft gels by mouth daily for 8 weeks<br>* Other names: Zemplar;Drug: Placebo<br>* Two soft gels by mouth daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Area Under the Curve (AUC) | Glucose AUC during a 2-hour oral glucose tolerance test | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Vitamin D, Paricalcitol, Placebo, Kidney, Renal, Oxidative Stress, Immune cell function, Glucose, Glucose tolerance