The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Information source: Indiana University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: Paricalcitol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s):
Rajiv Agarwal, MD, Principal Investigator, Affiliation: Indiana University
Overall contact:
Jennifer Bills, Phone: 317-988-4692, Email: jebills@iupui.edu
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.
Clinical Details
Official title: The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Creatinine Clearance
Secondary outcome: Serum Creatinine24-hour urine creatinine excretion rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jennifer Bills, Phone: 317-988-4692, Email: jebills@iupui.edu
Roudebush VA Medical Center, Indianapolis, Indiana 46202, United States; Recruiting
Rajiv Agarwal, MD, Principal Investigator
Additional Information
Starting date: August 2010
Last updated: January 31, 2011
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