The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate|
- 24-hour Urine Creatinine Excretion Rate [ Time Frame: 1 Week ] [ Designated as safety issue: No ]We expect the 24 hour urine creatinine excretion rate to show no differences between groups.
- Creatinine Clearance [ Time Frame: 1 Week ] [ Designated as safety issue: No ]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 [ Time Frame: 1 Week ] [ Designated as safety issue: No ]We expect serum creatinine to confirm the results of creatinine clearance.
|Study Start Date:||August 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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.
2 mcg oral Paricalcitol once per day for 7 days
Other Name: Zemplar
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163162
|United States, Indiana|
|Roudebush VA Medical Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Rajiv Agarwal, MD||Indiana University|