Clinical trial NCT03749356: Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
Official title: Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus Capsule(TacroBell SR Cap.) in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
timeFrame: until 24 weeks
Secondary outcomes:
measure: Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
timeFrame: until 24 weeks
measure: Pathological results of acute rejection
timeFrame: until 24 weeks
measure: Survival rate of transplated organ
timeFrame: at 24 weeks
measure: Survival rate of Patients
timeFrame: at 24 weeks
measure: Serum-Cr, eGFR
timeFrame: at 24 weeks
measure: Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
timeFrame: until 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital
name: Yu Seun Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: