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NCT Number: NCT00428246

Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation

The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.

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Key information

Conditions

Chronic Kidney Disease Cardiovascular Diseases Chronic Disease Disease Attributes Endothelial Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard A. Rodebush VA Medical Center

Indianapolis, Indiana, 46202, United States

About this study

We hypothesize that use of paricalcitol in patients with chronic kidney disease will lead to improvement in oxidative stress, inflammation, endothelial function and subsequently ambulatory blood pressures and glomerular filtration rate. We will pursue our hypothesis by the three specific aims:

Aim 1: To compare oxidative stress markers in patients treated with paricalcitol before and after the study. Aim 2: To measure endothelial function by flow mediated dilation in patients with chronic kidney disease before and after paricalcitol. Aim 3: To measure actigraphy guided ambulatory blood pressure and GFR in the absence of changes in anti-hypertensive medications in patients with chronic kidney disease.

The study will be double blind randomized pilot trial in 24 patients with chronic kidney disease with 1:1:1 allocation to paricalcitol 1 microgram: paricalcitol 2 microgram: Placebo.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
  • Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
  • Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
  • Hemoglobulin A1C< 11%

Exclusion criteria

  • Patients taking vitamin D analogs
  • Calcium> 10 mg/dL
  • Phosphorus>6 mg/dL
  • Patients with anticipated need of dialysis in the next 6 weeks
  • Patients unstable in the opinion of the investigator
  • Patients who have emergent need for starting IV iron
  • Patients who will be started on statins within the next 6 weeks
  • Patients currently taking PDE5 inhibitors
  • Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
  • Patients known to be HIV positive
  • Patients who can not give informed consent

Treatment and study plan

Paricalcitol

Drug

1 mcg or 2 mcg for 4 weeks.

Other names: Zemplar

Placebo

Drug

Placebo

Primary outcomes

  1. Anti-Inflammatory Effects of Paricalcitol

    Time frame: 6 weeks

    change in hsCRP level from baseline to 4 weeks

  2. Endothelial Protectant Effects of Paricalcitol

    Time frame: 6 weeks

Secondary outcomes

  1. Effect of Paricalcitol on Hypertension

    Time frame: 6 weeks

  2. Effect of Paricalcitol on Kidney Function

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Abbott

Registry information

Official study title

Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 29, 2007
Registry last updated
Jun 3, 2009

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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