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Completed

NCT Number: NCT00915876

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center South Clinical Campus

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paricalcitol

Drug

paricalcitol 1 mcg QD x 8 weeks

Placebo

Drug

Placebo for Paricalcitol 1 mcg QD x 8 weeks

Primary outcomes

  1. Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Amy Barton Pai

Other

Collaborators

  • Albany College of Pharmacy and Health Sciences

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 8, 2009
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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