NCT01363752

A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.

A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 853 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

Detailed description

This study will evaluate the potential to reduce nephrotoxic calcineurin inhibitors (CNI) therapy by lowering tacrolimus exposure from Advagraf® in combination with the non-nephrotoxic immunosuppressant sirolimus to avoid the risk of acute graft rejection, compared with an Advagraf® and Mycophenolate Mofetil (MMF) immunosuppressive regimen.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Advagraf	oral
DRUG	Mycophenolate Mofetil	oral
DRUG	Sirolimus	oral
DRUG	Corticosteroids	i.v. and oral

Timeline

• Start date: 2011-03-08
• Primary completion: 2013-09-18
• Completion: 2013-09-18
• First posted: 2011-06-02
• Last updated: 2024-10-31

Locations

58 sites across 17 countries: Australia, Austria, Belarus, Belgium, Czechia, France, Germany, Hong Kong, Hungary, Italy, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye)