Back to resultsThe Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate (Paricalcitol)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paricalcitol
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Vitamin D
Eligibility Criteria
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
Sites / Locations
- Roudebush VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paricalcitol
Arm Description
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.
Outcomes
Primary Outcome Measures
24-hour Urine Creatinine Excretion Rate
We expect the 24 hour urine creatinine excretion rate to show no differences between groups.
Secondary Outcome Measures
Creatinine Clearance
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.
Serum Creatinine
We expect serum creatinine to confirm the results of creatinine clearance.
Full Information
NCT ID
NCT01163162
First Posted
July 14, 2010
Last Updated
April 2, 2013
Sponsor
Indiana University
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT01163162
Brief Title
The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Acronym
Paricalcitol
Official Title
The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Vitamin D
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
Zemplar
Intervention Description
2 mcg oral Paricalcitol once per day for 7 days
Primary Outcome Measure Information:
Title
24-hour Urine Creatinine Excretion Rate
Description
We expect the 24 hour urine creatinine excretion rate to show no differences between groups.
Time Frame
1 Week
Secondary Outcome Measure Information:
Title
Creatinine Clearance
Description
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.
Time Frame
1 Week
Title
Serum Creatinine
Description
We expect serum creatinine to confirm the results of creatinine clearance.
Time Frame
1 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Agarwal, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roudebush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21716260
Citation
Agarwal R, Hynson JE, Hecht TJ, Light RP, Sinha AD. Short-term vitamin D receptor activation increases serum creatinine due to increased production with no effect on the glomerular filtration rate. Kidney Int. 2011 Nov;80(10):1073-9. doi: 10.1038/ki.2011.207. Epub 2011 Jun 29.
Results Reference
derived
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The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
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