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

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT00915876

Run by

Amy Barton Pai

People needed

41

Starts

2009-03-01

Expected to finish

2011-03-01

Last updated by the study team

2016-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Albany Medical Center South Clinical Campus — Albany, New York, United States

Full record on ClinicalTrials.gov

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