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The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate (Paricalcitol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01163162
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Information provided by (Responsible Party):
Indiana University

Brief Summary:
The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Paricalcitol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Paricalcitol
After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
Drug: Paricalcitol
2 mcg oral Paricalcitol once per day for 7 days
Other Name: Zemplar

Primary Outcome Measures :
  1. 24-hour Urine Creatinine Excretion Rate [ Time Frame: 1 Week ]
    We expect the 24 hour urine creatinine excretion rate to show no differences between groups.

Secondary Outcome Measures :
  1. Creatinine Clearance [ Time Frame: 1 Week ]
    The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.

  2. Serum Creatinine [ Time Frame: 1 Week ]
    We expect serum creatinine to confirm the results of creatinine clearance.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Stage 3 or 4 CKD
  • Ability to give informed consent

Exclusion Criteria:

  • Serum Calcium > 10 g/dL
  • Serum Phosphorous > 6 g/dL
  • On > 400 units/d Vitamin D therapy
  • Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine secretion
  • On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar)
  • Allergic to radiocontrast dye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01163162

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United States, Indiana
Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Principal Investigator: Rajiv Agarwal, MD Indiana University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Indiana University Identifier: NCT01163162    
Other Study ID Numbers: 1003-15
First Posted: July 15, 2010    Key Record Dates
Results First Posted: May 21, 2013
Last Update Posted: May 21, 2013
Last Verified: April 2013
Keywords provided by Indiana University:
Chronic Kidney Disease
Vitamin D
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency