NCT02036554

Evaluate Efficacy Study of Combination Therapy of Everolimus and Low Dose Tacrolimus in Renal Allograft Recipients

To Evaluate Prevention Effect Of Everolimus and Low-dose Tacrolimus in Comparison With Standard-dose Tacrolimus Therapy With Mycophenolic Acid on the New Onset Diabetes Mellitus After Transplantation in the Renal Allograft Recipients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation in the renal allograft recipients

Detailed description

An open-label, randomized, multi-center, comparative parallel study to evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation in the renal allograft recipients: PROTECT study

Conditions

• Kidney; Complications, Allograft

Interventions

Type	Name	Description
DRUG	Everolimus	Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
DRUG	Tacrolimus	Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
DRUG	Mycophenolic acid	Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-01-15
• Last updated: 2014-09-25

Locations

1 site across 1 country: South Korea