- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749356
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients (OPIRUS)
January 3, 2021 updated by: Chong Kun Dang Pharmaceutical
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Severance Hospital, Yonsei University Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Once-Daily Tacrolimus
One arm: TacroBell SR Cap.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
Time Frame: until 24 weeks
|
The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
|
until 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
Time Frame: until 24 weeks
|
The frequency and Incidence
|
until 24 weeks
|
Pathological results of acute rejection
Time Frame: until 24 weeks
|
By Banff classification categories
|
until 24 weeks
|
Survival rate of transplated organ
Time Frame: at 24 weeks
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Kaplan-Meier
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at 24 weeks
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Survival rate of Patients
Time Frame: at 24 weeks
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Kaplan-Meier
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at 24 weeks
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Serum-Cr, eGFR
Time Frame: at 24 weeks
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eGFR using CKD-epi method
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at 24 weeks
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Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
Time Frame: until 24 weeks
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safety data
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until 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yu Seun Kim, Ph.D, Severance Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 5, 2018
Primary Completion (ACTUAL)
July 30, 2020
Study Completion (ACTUAL)
December 4, 2020
Study Registration Dates
First Submitted
November 14, 2018
First Submitted That Met QC Criteria
November 19, 2018
First Posted (ACTUAL)
November 21, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 5, 2021
Last Update Submitted That Met QC Criteria
January 3, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 211KT18008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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