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

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Paricalcitol

• Registration Number: NCT01163162
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Study Start: 2010-08
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Status Verified: 2013-04
• Results First Submitted: 2013-04-02
• Results First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Results First Posted: 2013-05-21
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paricalcitol	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.

Primary Outcome Measures

Name	Time	Method
24-hour Urine Creatinine Excretion Rate	1 Week	We expect the 24 hour urine creatinine excretion rate to show no differences between groups.

Secondary Outcome Measures

Name	Time	Method
Creatinine Clearance	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.
Serum Creatinine	1 Week	We expect serum creatinine to confirm the results of creatinine clearance.

Trial Locations

Locations (1)

Roudebush VA Medical Center; 🇺🇸 Indianapolis, Indiana, United States