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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Paricalcitol

Intervention Type DRUG

2 mcg oral Paricalcitol once per day for 7 days

Interventions

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Paricalcitol

2 mcg oral Paricalcitol once per day for 7 days

Intervention Type DRUG

Other Intervention Names

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Zemplar

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No