Kidney TransplantationPhase 4NCT04700709
Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.
A Phase 4 study testing Sirolimus Tab. and Mycophenolate Mofetil Cap./Tab. 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 of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Sirolimus Tab. and Mycophenolate Mofetil Cap./Tab.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2021to Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [Time of Screening]
- Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation
- More than the age of 19 years old
- Agreement with written informed consent
- [Time of Randomization]
- Patients who have transplanted Kidney within 4 weeks(25 days to 35 days)
- Patients who take CNI plus MMF after kidney transplantation
Who cannot join
- [Time of Screening]
- Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs
- PRA > 50% before desenitization or positive results of DSA
- Receive a kidney from a related donor who showed HLA identical
- Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor
- Allergic/hypersensitivity reaction in the history of Investigational drugs or additives
Show all 18Show fewer
- Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
- Patient has conversation impairment because of mental illness within 6months
- Participated in other trial within 4 weeks
- In investigator's judgement
- [Time of Randomization]
- Patients with acute rejection who have been clinically treated after kidney transplantation
- At the time of Randomization
- 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
- Patients who had plasmapheresis within 1 week
- Patents who had a record of taking mTOR inhibitor before
- In investigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared With Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO Incompatible De Novo Living Kidney Transplant Recipients. [ART Study]
The purpose of this study is to evaluate the efficacy and safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
Read the detailed description
This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
- Conditions
- Kidney Transplantation
- Being tested
- Sirolimus Tab., Mycophenolate Mofetil Cap./Tab.
- Keywords
- Kidney Transplantation, ABO incompatible, Sirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus Tab.Drug
Also called RaparoBell® Tab.
Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~8ng/ml.
Mycophenolate Mofetil Cap./Tab.Drug
Also called Myrept® Cap./Tab.
Up to 1g BID(total 2g daily), PO
| Study group | Role | What they receive |
|---|---|---|
| RaparoBell® Tablet | Experimental | ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. Receives: Drug: Sirolimus Tab. |
| Mycophenolate Mofetil Tablet/Capsule | Active comparator | ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. Receives: Drug: Mycophenolate Mofetil Cap./Tab. |
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-confired acute rejection, graft loss, death, or follow-up failure
Measured: Until 48 weeks after taking medicine
Secondary outcomes (6)
Incidence of composite efficacy failure
Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure
Measured: Until 24 weeks after taking medicine
Incidence of biopsy-confirmed acute rejection
Banff Criteria
Measured: Until 24weeks and 48weeks after taking medicine
The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy
Banff Criteria
Measured: Until 24weeks and 48weeks after taking medicine
Survival rate
transplanted organ and patients
Measured: Until 24weeks and 48weeks after taking medicine
Function of Kidney
eGFR using MDRD(Modification of Diet in Renal Disease) method
Measured: Until 24weeks and 48weeks after taking medicine
Incidence of CMV, BKV infection
Incidence of CMV, BKV infection
Measured: Until 24weeks and 48weeks after taking medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (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.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu Ha Huh, M.D, Ph.D, Study chair, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700709
- Sponsor's protocol ID
- B110_01KT2002
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared With Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO Incompatible De Novo Living Kidney Transplant Recipients. [ART Study]
- ClinicalTrials.gov ID
- NCT04700709
- Acronym / sponsor ID
- B110_01KT2002
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, ABO incompatible, Sirolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 8 Jan 2021 (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 of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
Detailed description
This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
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: Sirolimus Tab.ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. |
| Mycophenolate Mofetil Tablet/Capsule | Active comparator | Drug: Mycophenolate Mofetil Cap./Tab.ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- [Time of Screening]
- Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation
- More than the age of 19 years old
- Agreement with written informed consent
- [Time of Randomization]
Key exclusion criteria (18 listed)
- [Time of Screening]
- Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs
- PRA > 50% before desenitization or positive results of DSA
- Receive a kidney from a related donor who showed HLA identical
- Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor
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 |
|---|---|---|
| Sirolimus Tab.Also: RaparoBell® Tab.Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~8ng/ml. | Drug | RaparoBell® Tablet |
| Mycophenolate Mofetil Cap./Tab.Also: 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 48 weeks after taking medicine
Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure
6 secondary outcomes
Incidence of composite efficacy failure
Time frame: Until 24 weeks after taking medicine
Incidence of biopsy-confirmed acute rejection
Time frame: Until 24weeks and 48weeks after taking medicine
The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy
Time frame: Until 24weeks and 48weeks after taking medicine
Survival rate
Time frame: Until 24weeks and 48weeks after taking medicine
Function of Kidney
Time frame: Until 24weeks and 48weeks after taking medicine
Incidence of CMV, BKV infection
Time frame: Until 24weeks and 48weeks after taking medicine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Kyu Ha Huh, M.D, Ph.D study chair
Severance Hospital
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 Tab. and Mycophenolate Mofetil Cap./Tab. 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyu Ha Huh, M.D, Ph.D (+82-2-2228-2138, KHHUH@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite efficacy failure (time frame: Until 48 weeks after taking medicine). 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 8 Jan 2021.