Phase 2 N=22 Randomized Quadruple-blind Treatment

Metabolic Effects of Paricalcitol

Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT01003275 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcome: Primary: Glucose Area Under the Curve (AUC) — 20817; 21139 mg*min/dL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Paricalcitol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Glucose Area Under the Curve (AUC)	20817; 21139	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01003275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.