RANDOMIZED CONTROLLED TRIAL OF ONCE-DAILY REGIMEN OF EXTENDED-RELEASE TACROLIMUS AND SIROLIMUS VERSUS EXTENDED-RELEASE TACROLIMUS AND MMF FOR KIDNEY TRANSPLANTATIO
Phase 4
Recruiting
- Conditions
- Maintenance immunosuppressive of kidney transplantOnce daily,Immunosuppressive,kidney transplantation,rapamycin
- Registration Number
- TCTR20190228005
- Lead Sponsor
- ephrology Unit, Faculty of Medicine, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Kidney transplantation more than 4 months
- Age more than 18 years
- ABO compatible transplantation
- First kidney transplantation
Exclusion Criteria
- Combined organ transplantation
- eGFR less than 40 ml/min/1.73m2
- Proteinuria more than 500 mg/day
- Panel reactive antibody (PRA) more than 30%
- Donor specific antibody posiive
- Crossmatch positive
- Hepatitis B, Hepatitis C , HIV co-infection
- Severe restrictive, obstructive pulmonary disease
- History of malignancy
- History of BK virus nephropathy
- History of CMV disease
- Pregnancy
- Lactation
- uncontrolled Diabetes, dyslipidemia, hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eGFR 12 months after treatment assigned creatinine and calculated to eGFR
- Secondary Outcome Measures
Name Time Method eGFR 6 months after treatment assigned creatinine and calculated to eGFR,all cause mortality 12 months after treatment assigned report death ,Allograft survival 12 months after treatment assigned repot allograft survival,urine protein 12 months 24 hour urine protein,quality of life 12 months questionnaire,de novo donor specific antibody 12 months donor specific antibody,de novo donor specific antibody 12 months donor specific antibody,Biopsy provecute rejection (BPAR) 12 months allograft rejection,CNI nephrotoxicity 12 months CNI nephrotoxicity,Lipid 12 months Cholesterol TG LDL HD