NCT00818194

Comparison of Extended Release Tacrolimus (Advagraf) and Cyclosporine A Microemulsion on Renal Function in Healthy Volunteers

A Comparison of Effects of Short-term Low Dose Exposure of Advagraf® and Neoral® Microemulsion Cyclosporine A on Renal Perfusion and Function in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the effects of steady state tacrolimus vs. cyclosporine on renal pharmacodynamics in healthy volunteers.

Detailed description

This study seeks to evaluate the renal physiological responses of short-term maintenance level doses of CNIs in healthy volunteers to determine if daily perturbations in renal physiology exist, and if confirmed, whether they differ between CNIs and thus may contribute by different mechanisms to the progression of CAN.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	extended release tacrolimus	oral
DRUG	cyclosporine A microemulsion	oral

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2009-01-07
• Last updated: 2014-07-09

Locations

1 site across 1 country: Canada