NCT00693381

Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus	oral
DRUG	Mycophenolate Mofetil	oral
DRUG	methylprednisolone and prednisone	IV and oral

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2008-06-09
• Last updated: 2014-09-18

Locations

14 sites across 4 countries: Czechia, Hungary, Poland, Slovakia