Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
- Conditions
- Kidney Transplant
- Interventions
- Drug: TacroBell SR cap.
- Registration Number
- NCT03749356
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.
- Detailed Description
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
- Over 20 years old(male or female)
- Patients who are planning to receive a kidney from a deceased or a living non-related/related donor
- Agreement with written informed consent
-
Previously received organs other than kidneys or who are planed to be transplanted simultaneously
-
Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient
-
Receive a kidney from a related donor who showed HLA-0 mismatch (identical)
-
Undergo desensitization therapy with high sensitization
-
Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.]
-
Patients or donors who have positive HIV test result
-
Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders
-
Severe systemic infection requiring treatment
-
Prior to the kidney transplantation
- Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
- WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/mm^3
-
Pregnant women or nursing mothers
-
Fertile women who not practice contraception with appropriate methods
-
Participated in other trial within 4 weeks
-
In investigator's judgment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Once-Daily Tacrolimus TacroBell SR cap. One arm: TacroBell SR Cap.
- Primary Outcome Measures
Name Time Method Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) until 24 weeks The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
- Secondary Outcome Measures
Name Time Method Survival rate of transplated organ at 24 weeks Kaplan-Meier
Survival rate of Patients at 24 weeks Kaplan-Meier
Serum-Cr, eGFR at 24 weeks eGFR using CKD-epi method
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events until 24 weeks safety data
Incidence of biopsy-confirmed acute rejection(TCMR, AMR) until 24 weeks The frequency and Incidence
Pathological results of acute rejection until 24 weeks By Banff classification categories
Trial Locations
- Locations (1)
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System🇰🇷Seoul, Korea, Republic of