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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01163162
First received: July 14, 2010
Last updated: October 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Chronic Kidney Disease
 Drug: Paricalcitol
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Creatinine Clearance [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
    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 heterogeneity between periods.


Secondary Outcome Measures:
  • Serum Creatinine [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
    We expect serum creatinine to confirm the results of creatinine clearance.

  • 24-hour urine creatinine excretion rate [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
    We expect the 24 hour urine creatinine excretion rate to show no heterogeneity between groups.


Estimated Enrollment: 16
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163162

Locations
United States, Indiana
Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Abbott
Investigators
Principal Investigator: Rajiv Agarwal, MD Indiana University
  More Information

No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01163162     History of Changes
Other Study ID Numbers: 1003-15
Study First Received: July 14, 2010
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Chronic Kidney Disease
Vitamin D

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ergocalciferols
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 17, 2012