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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00428246
First received: January 25, 2007
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Endothelial Dysfunction
Inflammation
Hypertension
Drug: paricalcitol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Anti-Inflammatory Effects of Paricalcitol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Endothelial Protectant Effects of Paricalcitol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of Paricalcitol on Hypertension [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Effect of Paricalcitol on Kidney Function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
1 mcg paricalcitol
Drug: paricalcitol
1 mcg or 2 mcg for 4 weeks.
Other Name: Zemplar
Active Comparator: 2
2 mcg paricalcitol
Drug: paricalcitol
1 mcg or 2 mcg for 4 weeks.
Other Name: Zemplar
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428246

Locations
United States, Indiana
Richard A. Rodebush VA Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Abbott
Investigators
Principal Investigator: Rajiv Agarwal, MD Indiana University School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00428246     History of Changes
Other Study ID Numbers: 0510-04
Study First Received: January 25, 2007
Results First Received: April 6, 2009
Last Updated: April 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Chronic Kidney Disease
Endothelial dysfunction
Inflammation
Hypertension
paricalcitol
Blood pressure
Vitamin D
Glomerular filtration rate

Additional relevant MeSH terms:
Hypertension
Inflammation
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014