Trials / Completed
CompletedNCT03749356
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Chong Kun Dang Pharmaceutical · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TacroBell SR cap. | * Orally, once-daily in the morning * After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~12ng/ml for 0 to 3months and then at 3\~8ng/ml for 3 to 6months of study treatment. |
Timeline
- Start date
- 2018-09-05
- Primary completion
- 2020-07-30
- Completion
- 2020-12-04
- First posted
- 2018-11-21
- Last updated
- 2021-01-05
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03749356. Inclusion in this directory is not an endorsement.