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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Paricalcitol; Drug: Placebo

• Registration Number: NCT00915876
• Lead Sponsor: Amy Barton Pai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-10
• Results First Submitted: 2016-10-07
• Results First Submitted QC: 2016-10-07
• Last Update Submitted: 2016-10-07
• Results First Posted: 2016-12-02
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paricalcitol	Paricalcitol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56	Day 28 and Day 56	Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56

Trial Locations

Locations (1)

Albany Medical Center South Clinical Campus; 🇺🇸 Albany, New York, United States