Kidney Transplant ImmunosuppressionPhase 4NCT06114953
Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
A Phase 4 study testing Mizoribine and Mycophenolate Mofetil in people with Kidney Transplant Immunosuppression, run by Lee's Pharmaceutical Limited at 6 sites in China.
Trial summary
This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant Immunosuppression
- What is being tested?
- Mizoribine and Mycophenolate Mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2023to 1 Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) After donor kidney transplantation;
- 2) Adult recipients aged 18-75 years, regardless of gender;
- 3) First-time kidney transplant recipients;
- 4) Voluntarily sign written informed consent.
Who cannot join
- 1) Multiple organ transplantation;
- 2) DSA positive patients had ABO incompatibility and PRA>30%;
- 3) Recipients with active signs of infection;
- 4) Recipients with leukocyte counts below 3,000/mm3;
- 5) Pregnant women, breastfeeding women or women who do not wish to use appropriate contraceptive methods during the study period;
- 6) Patients with severe gastrointestinal diseases and active peptic ulcer disease;
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- 7) suffering from any mental illness;
- 8) Patients with severe heart disease and abnormal heart function;
- 9) Subjects who are known to be allergic to the test drug;
- 10) Recipients judged unsuitable for inclusion by other competent physicians.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
YICHEN ZHU, Doctor, yczhu@ccmu.edu.cn
- Recruiting
West China Hospital, Sichuan University
Chengdu
TAO LIN, Doctor, kidney5@163.com
- Recruiting
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
YULIN NIU, Doctor, nniuyulin@163.com
- Recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
XUYONG SUN, Doctor, sxywn@sohu.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
WEIJIE ZHANG, Doctor, wjzhangtj@126.com
- Not yet recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
GUIWEN FENG, Doctor, fengguiwen@zzu.edu.cn
About this study
This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. All patients meeting the inclusion criteria were randomly assigned 1:1 to either Mizoribine or Mycophenolate Mofetil for 12 months. At the baseline of follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect.
Read the detailed description
This is a multi-center, prospective, non-inferior, randomized controlled clinical study. The sick individuals and their families participating in the trial voluntarily participate and sign the "informed consent" under the premise of fully understanding the treatment plan; The treatment plan was approved by the hospital ethics committee.
A total of 152 patients from six centers nationwide will be enrolled starting from the date when the center's ethics are officially approved. The qualified recipients of donor kidney transplantation were randomly assigned 1:1 to the control group and the experimental group. The control group was treated with glucocorticoid + MPA+ tacrolimus for 12 months, and the experimental group was treated with glucocorticoid +MZR+ tacrolimus for 12 months. All subjects were followed up on the day of renal transplantation, at 1, 2 weeks and 1, 2, 3, 6, 9 and 12 months after the operation: history collection, incidence of acute rejection, survival rate of recipients, survival rate of transplanted kidney, liver and kidney function, blood routine and urine routine; Cytomegalovirus (CMV)-DNA and BK virus (BKV)-DNA copy levels were detected in blood at 1, 3, 6, 9, and 12 months after renal transplantation to assess CMV and BKV infection. Adverse reactions were recorded during follow-up.
- Conditions
- Kidney Transplant Immunosuppression
- Being tested
- Mizoribine, Mycophenolate Mofetil
- Keywords
- Immunosuppression, Kidney Transplant Rejection, mizoribine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MizoribineDrug
Mizoribine+glucocorticoid+tacrolimus after kidney transplantation
Also called Mycophenolate Acid
Mycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Mizoribine group | Experimental | Mizoribine, glucocorticoid, tacrolimus Receives: Drug: Mizoribine |
| Mycophenolate group | Active comparator | Mycophenolate mofetil, glucocorticoid, tacrolimus Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine
Monitoring serum creatinine.
Measured: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant ImmunosuppressionStudies 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
- Model description
- Experimental group: glucocorticoid, mizoribine, tacrolimus; Control group: glucocorticoid, mycophenolate mofetil.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TAO LIN, Doctor, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114953
- Sponsor's protocol ID
- BRDN-LEES-2023-10
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD shared plan.
Publications
Shi Y, Liu H, Chen XG, Shen ZY. Efficacy and Safety of Mizoribine Combined With Tacrolimus in Living Donor Kidney Transplant Recipients: 3-Year Results by a Chinese Single Center Study. Transplant Proc. 2019 Jun;51(5):1337-1342. doi: 10.1016/j.transproceed.2019.03.014.
PubMed 31155174Ju MK, Huh KH, Park KT, Kim SJ, Cho BH, Kim CD, So BJ, Kang CM, Lee S, Joo DJ, Kim YS. Mizoribine versus mycophenolate mofetil in combination therapy with tacrolimus for de novo kidney transplantation: evaluation of efficacy and safety. Transplant Proc. 2013 May;45(4):1481-6. doi: 10.1016/j.transproceed.2012.12.028.
PubMed 23726602Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093.
PubMed 28810721Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
PubMed 39382091
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
- ClinicalTrials.gov ID
- NCT06114953
- Acronym / sponsor ID
- BRDN-LEES-2023-10
- Conditions
- Kidney Transplant Immunosuppression
- Keywords
- Immunosuppression, Kidney Transplant Rejection, mizoribine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 2 Nov 2023 (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.
This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. All patients meeting the inclusion criteria were randomly assigned 1:1 to either Mizoribine or Mycophenolate Mofetil for 12 months. At the baseline of follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect.
Detailed description
This is a multi-center, prospective, non-inferior, randomized controlled clinical study. The sick individuals and their families participating in the trial voluntarily participate and sign the "informed consent" under the premise of fully understanding the treatment plan; The treatment plan was approved by the hospital ethics committee.
A total of 152 patients from six centers nationwide will be enrolled starting from the date when the center's ethics are officially approved. The qualified recipients of donor kidney transplantation were randomly assigned 1:1 to the control group and the experimental group. The control group was treated with glucocorticoid + MPA+ tacrolimus for 12 months, and the experimental group was treated with glucocorticoid +MZR+ tacrolimus for 12 months. All subjects were followed up on the day of renal transplantation, at 1, 2 weeks and 1, 2, 3, 6, 9 and 12 months after the operation: history collection, incidence of acute rejection, survival rate of recipients, survival rate of transplanted kidney, liver and kidney function, blood routine and urine routine; Cytomegalovirus (CMV)-DNA and BK virus (BKV)-DNA copy levels were detected in blood at 1, 3, 6, 9, and 12 months after renal transplantation to assess CMV and BKV infection. Adverse reactions were recorded during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: glucocorticoid, mizoribine, tacrolimus; Control group: glucocorticoid, mycophenolate mofetil.
| Arm | Type | Receives |
|---|---|---|
| Mizoribine group | Experimental | Drug: MizoribineMizoribine, glucocorticoid, tacrolimus |
| Mycophenolate group | Active comparator | Drug: Mycophenolate MofetilMycophenolate mofetil, glucocorticoid, tacrolimus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) After donor kidney transplantation;
- 2) Adult recipients aged 18-75 years, regardless of gender;
- 3) First-time kidney transplant recipients;
- 4) Voluntarily sign written informed consent.
Key exclusion criteria (10 listed)
- 1) Multiple organ transplantation;
- 2) DSA positive patients had ABO incompatibility and PRA>30%;
- 3) Recipients with active signs of infection;
- 4) Recipients with leukocyte counts below 3,000/mm3;
- 5) Pregnant women, breastfeeding women or women who do not wish to use appropriate contraceptive methods during the study period;
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 |
|---|---|---|
| MizoribineMizoribine+glucocorticoid+tacrolimus after kidney transplantation | Drug | Mizoribine group |
| Mycophenolate MofetilAlso: Mycophenolate AcidMycophenolate Mofetil+glucocorticoid+tacrolimus after kidney transplantation | Drug | Mycophenolate group |
Primary outcome
Serum creatinine
Time frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months
Monitoring serum creatinine.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Results publication: PubMed 31155174Shi Y, Liu H, Chen XG, Shen ZY. Efficacy and Safety of Mizoribine Combined With Tacrolimus in Living Donor Kidney Transplant Recipients: 3-Year Results by a Chinese Single Center Study. Transplant Proc. 2019 Jun;51(5):1337-1342. doi: 10.1016/j.transproceed.2019.03.014.
- Results publication: PubMed 23726602Ju MK, Huh KH, Park KT, Kim SJ, Cho BH, Kim CD, So BJ, Kang CM, Lee S, Joo DJ, Kim YS. Mizoribine versus mycophenolate mofetil in combination therapy with tacrolimus for de novo kidney transplantation: evaluation of efficacy and safety. Transplant Proc. 2013 May;45(4):1481-6. doi: 10.1016/j.transproceed.2012.12.028.
- Results publication: PubMed 28810721Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093.
- Derived from this study: PubMed 39382091Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
- Individual participant dataSharing planned: No. No IPD shared plan.
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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.
TAO LIN, Doctor study chair
West China Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mizoribine and Mycophenolate Mofetil in people with Kidney Transplant Immunosuppression, run by Lee's Pharmaceutical Limited at 6 sites in China.
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 4 inclusion and 10 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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 SHI JI HAN, Master (13929517813, shiji.han@leespharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine (time frame: Postoperative 1 week, 2 weeks, 1month, 2，3，6，9，12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06114953, which also lists 4 linked publications.
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 2 Nov 2023.