NCT01304836

A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids

Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,166 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

Detailed description

The primary objective of this study is to compare an Immunosuppressive regimen with 10 days of corticosteroids with a regimen with only an optional intra-op bolus of corticosteroids with regard to incidence of new onset Diabetes Mellitus as per the American Diabetic Association (ADA) criteria at any point up to 24 weeks after kidney transplantation.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Advagraf	oral
DRUG	Mycophenolate Mofetil	oral
DRUG	Simulect	IV
DRUG	Corticosteroids	IV \& oral

Timeline

• Start date: 2011-01-22
• Primary completion: 2013-05-22
• Completion: 2013-05-22
• First posted: 2011-02-28
• Last updated: 2024-11-01

Locations

100 sites across 24 countries: Australia, Belgium, Colombia, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland