RANDOMIZED CONTROLLED TRIAL OF ONCE-DAILY REGIMEN OF EXTENDED-RELEASE TACROLIMUS AND SIROLIMUS VERSUS EXTENDED-RELEASE TACROLIMUS AND MMF FOR KIDNEY TRANSPLANTATION

A MULTICENTER, RANDOMIZED CONTROLLED TRIAL OF LATE CONVERSION TO ONCE-DAILY REGIMEN OF EXTENDED-RELEASE TACROLIMUS AND SIROLIMUS VERSUS EXTENDED-RELEASE TACROLIMUS AND MMF FOR KIDNEY TRANSPLANTATION

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190228005

Enrollment

Registered

2019-02-28

Start date

2017-04-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maintenance immunosuppressive of kidney transplant Once daily&#44

Interventions

Extended&#45

release tacrolimus and sirolimus,Extended&#45

release tacrolimus and MMF

Experimental Drug,Active Comparator Drug

Once daily,Twice daily

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: - Kidney transplantation more than 4 months - Age more than 18 years - ABO compatible transplantation - First kidney transplantation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
eGFR 12 months after treatment assigned creatinine and calculated to eGFR	—

Secondary

Measure	Time frame
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 HDL	—

Measure

Time frame

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 HDL

—

Contacts

Public ContactNatavudh Townamchai

Chulalongkorn University

ntownamchai@gmail.com0894904222

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

RANDOMIZED CONTROLLED TRIAL OF ONCE&#45;DAILY REGIMEN OF EXTENDED&#45;RELEASE TACROLIMUS AND SIROLIMUS VERSUS EXTENDED&#45;RELEASE TACROLIMUS AND MMF FOR KIDNEY TRANSPLANTATION