Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients
Phase 4
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Drug: reduced dose tacrolimus and conventional myforticDrug: routine dose tacrolimus and less myfortic
- Registration Number
- NCT01159080
- Lead Sponsor
- Asan Medical Center
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description reduced dose tacrolimus and conventional myfortic reduced dose tacrolimus and conventional myfortic - routine dose tacrolimus and less myfortic routine dose tacrolimus and less myfortic -
- Primary Outcome Measures
Name Time Method estimated GFR (MDRD equation)12 months after randomization 12 months after randomization
- Secondary Outcome Measures
Name Time Method Urine protein excretion 12 months after randomization 24hr urine collection or urine protein/creatinine ratio
graft survival 12 month after randomization 12 month graft survival
follow-up loss From randomization to 12 months after randomization frequency of follow-up loss
Treated or biopsy proven acute rejection From randomization to 12 months after randomization Allograft biopsy From randomization to 12 months after randomization number of performed allograft biopsy performed
estimated GFR change from randomization to end of the study 12 months after randomization calculated by MDRD equation and Nankivell equation
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Asan Medical Center, Korea, Republic of