Kidney TransplantationPhase 4NCT05193565
Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients
A Phase 4 study testing Sirolimus and Mycophenolate mofetil in people with Kidney Transplantation, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Sirolimus and Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Nov 2021to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who at least 1 year and less than 10 years after kidney transplantation
- Over 20 years old
- Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation
Who cannot join
- Patients who have transplanted organs other than kidney
- At the time of Screening
- 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
- Protein/Creatinine ratio≥1.0(mg/mg)
- Patents who had a record of taking mTOR inhibitor before 3 months
- In investigator's judgement
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea
Seoul
About this study
Official title: Multi-center, Open-label, Randomized Controlled Phase 4 Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients Undergoing Maintenance Therapy With CNI Plus MPA.[CORAL Study]
The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
Read the detailed description
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
- Conditions
- Kidney Transplantation
- Being tested
- Sirolimus, Mycophenolate mofetil
- Keywords
- Kidney Transplantation, Sirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called RaparoBell® Tab.
Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8ng/mL
Also called Myrept® Cap./Tab.
Up to 1g BID(total 2g daily), PO
| Study group | Role | What they receive |
|---|---|---|
| RaparoBell Tablet | Experimental | RaparoBell Tablet Receives: Drug: Sirolimus |
| Mycophenolate Mofetil Tablet/Capsule | Active comparator | Myrept Tablet/Capsule Receives: Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite efficacy failure
Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Measured: Until 24 weeks
Secondary outcomes (6)
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
The frequency and Incidence
Measured: Until 24 weeks
Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy
By Banff classification categories
Measured: Until 24 weeks
Survival rate of transplanted organ
Kaplan-Meier
Measured: Until 24 weeks
Survival rate of Patients
Kaplan-Meier
Measured: Until 24 weeks
Serum-Cr, eGFR
eGFR using MDRD
Measured: Until 24 weeks
Incidence of BKV, CMV infection
The frequency and Incidence
Measured: Until 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start19 Nov 2021
- Primary completionJul 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Berm Park, Ph.D, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193565
- Sponsor's protocol ID
- B110_02KT2103
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Randomized Controlled Phase 4 Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients Undergoing Maintenance Therapy With CNI Plus MPA.[CORAL Study]
- ClinicalTrials.gov ID
- NCT05193565
- Acronym / sponsor ID
- B110_02KT2103
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, Sirolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
Detailed description
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RaparoBell Tablet | Experimental | Drug: SirolimusRaparoBell Tablet |
| Mycophenolate Mofetil Tablet/Capsule | Active comparator | Drug: Mycophenolate mofetilMyrept Tablet/Capsule |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who at least 1 year and less than 10 years after kidney transplantation
- Over 20 years old
- Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation
Key exclusion criteria (7 listed)
- Patients who have transplanted organs other than kidney
- At the time of Screening
- Patents who had a record of taking mTOR inhibitor before 3 months
- In investigator's judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusAlso: RaparoBell® Tab.Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8ng/mL | Drug | RaparoBell Tablet |
| Mycophenolate mofetilAlso: Myrept® Cap./Tab.Up to 1g BID(total 2g daily), PO | Drug | Mycophenolate Mofetil Tablet/Capsule |
Primary outcome
Incidence of composite efficacy failure
Time frame: Until 24 weeks
Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
6 secondary outcomes
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
Time frame: Until 24 weeks
Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy
Time frame: Until 24 weeks
Survival rate of transplanted organ
Time frame: Until 24 weeks
Survival rate of Patients
Time frame: Until 24 weeks
Serum-Cr, eGFR
Time frame: Until 24 weeks
Incidence of BKV, CMV infection
Time frame: Until 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Berm Park, Ph.D study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sirolimus and Mycophenolate mofetil in people with Kidney Transplantation, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite efficacy failure (time frame: Until 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.