Metabolic Effects of Paricalcitol

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003275
• Other study ID #: 35501-D
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2009
• Last updated: April 9, 2014
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: April 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Paricalcitol
Two 1 mcg soft gels by mouth daily for 8 weeks
• Placebo
Two soft gels by mouth daily for 8 weeks

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Area Under the Curve (AUC)	Glucose AUC during a 2-hour oral glucose tolerance test	8 weeks	No