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

Chronic Kidney Disease Clinical Trial

— Paricalcitol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163162
• Other study ID #: 1003-15
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2010
• Last updated: April 2, 2013
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Paricalcitol
2 mcg oral Paricalcitol once per day for 7 days

Locations

Country	Name	City	State
United States	Roudebush VA Medical Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Urine Creatinine Excretion Rate	We expect the 24 hour urine creatinine excretion rate to show no differences between groups.	1 Week	No
Secondary	Creatinine Clearance	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	No
Secondary	Serum Creatinine	We expect serum creatinine to confirm the results of creatinine clearance.	1 Week	No