Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo

Chronic Kidney Disease Clinical Trial

Official title:

Effects of 19-nor-1α-dihydroxyvitamin D2 (Paricalcitol) Versus Placebo on Oxidative Stress and Vascular Reactivity in CKD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915876
• Other study ID #: Paricalcitol-AMC2443
• Status: Completed
• Phase: N/A
• First received: June 5, 2009
• Last updated: July 10, 2012
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: July 2012
• Source: Albany College of Pharmacy and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females = 18 years of age at the start of screening

• CKD with eGFR 15-60 mL/min/1.73m2 by MDRD

• Not expected to start dialysis for 4 months

• Serum intact PTH 70-200 pg/mL during screening period

• On stable ACEI/ARB regimen for 30 days prior to screening

Exclusion Criteria:

• History of any of the following diseases:

• congestive heart failure

• MI within the last 6 months

• history of cerebrovascular accident

• significant valvular disease

• malignancy

• Currently taking any vitamin D products

• Mean systolic blood pressure values > 190 or diastolic blood pressure values > 100 mm/Hg during the preceding 30 day period prior to screening

• Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker

• Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P > 55 mg2/dL2

• Currently receiving erythropoiesis stimulating agent or intravenous iron therapy

• Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Paricalcitol
paricalcitol 1 mg QD x 8 weeks
• Placebo
Placebo for Paricalcitol 1 mcg QD x 8 weeks

Locations

Country	Name	City	State
United States	Albany Medical Center South Clinical Campus	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albany College of Pharmacy and Health Sciences	Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the change in circulating ICAM-1.		8 weeks	No