NCT01159080

Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients

Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects Primary endpoints: 1. estimated GFR (MDRD equation) 12 months after randomization 2. estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	routine dose tacrolimus and less myfortic	oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day
DRUG	reduced dose tacrolimus and conventional myfortic	low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day

Timeline

• Start date: 2010-04-01
• Primary completion: 2016-10-30
• Completion: 2016-11-30
• First posted: 2010-07-09
• Last updated: 2017-03-14

Locations

1 site across 1 country: South Korea