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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once-Daily Tacrolimus | Experimental | One arm: TacroBell SR Cap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TacroBell SR cap. | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) | The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) | until 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy-confirmed acute rejection(TCMR, AMR) | The frequency and Incidence | until 24 weeks |
| Pathological results of acute rejection | By Banff classification categories |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Yu Seun Kim, Ph.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
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| until 24 weeks |
| Survival rate of transplated organ | Kaplan-Meier | at 24 weeks |
| Survival rate of Patients | Kaplan-Meier | at 24 weeks |
| Serum-Cr, eGFR | eGFR using CKD-epi method | at 24 weeks |
| Evaluate safety of TacroBell SR. cap. from number of participants with adverse events | safety data | until 24 weeks |