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

April 2, 2013 updated by: Indiana University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Roudebush VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Zemplar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Week
Serum Creatinine
Time Frame: 1 Week
We expect serum creatinine to confirm the results of creatinine clearance.
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Abbott

Investigators

  • Principal Investigator: Rajiv Agarwal, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 21, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1003-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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