Metabolic Effects of Paricalcitol

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Abbott
• Treatments: Ergocalciferols

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