Kidney Transplant RejectionPhase 4NCT05872568
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) in people with Kidney Transplant Rejection, run by Zhishui Chen.
Trial summary
At present, imitation EC-MPS have just come on the market, no clinical studies have confirmed the efficacy and safety of using imitation EC-MPS for immunosuppressive therapy after kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, aged 18-65;
- Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time;
- After kidney transplantation, patients were subjected to a routine triple immunosuppressive regimen, namely "mecophenol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" regimen;
- The patients signed informed consent, were able to follow up regularly and fully collect information related to this study.
Who cannot join
- Multi-organ recipients, such as those with heart, lung, liver and other organ transplants;
- ABO incompatible kidney transplant recipients;
- HLA antibodies or past/current population reactive antibody level (PRA) > 25% were preexisting in the recipient before renal transplantation;
- Allergic to EC-MPS or preparation components (hypersensitivity);
- Women with fertility potential who are pregnant, lactating or planning to become pregnant;
- Severe/uncontrolled concomitant infections or other serious medical problems;
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- Active bacterial, viral or fungal infections;
- Neutropenia (ANC<1.3×103/µL)
- Patients judged by the investigator to be unsuitable for inclusion in this study for other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients：A Large, Multiple-Center Prospective Study
At present, imitation EC-MPS have just come on the market, no clinical studies have confirmed the efficacy and safety of using imitation EC-MPS for immunosuppressive therapy after kidney transplantation. Therefore, there is an urgent need to conduct a multicenter study in China to provide further guidance for the use of imitated mycophenol sodium enteric-coated tablets in kidney transplant patients. Therefore, this study will analyze whether the anti-rejection effect of generic EC-MPS in the treatment of renal transplantation in Chinese population is equivalent to that of the original EC-MPS, in order to provide reference for clinical rational drug use.
Read the detailed description
Under the premise that tacrolimus is used as basic immunosuppressant, to explore the efficacy and safety of imitation mecophenol sodium enteric-coated tablets (EC-MPS) compared with the original preparation agent (Miv) in Chinese kidney transplant patients.
This study was divided into experimental group and control group. The experimental group was imitation mycophenol sodium enteric-coated tablets, and the control group was original mycophenol sodium enteric-coated tablets. Both groups were treated with the triple immunosuppressive regimen of "Mycopherol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" immediately after transplantation for at least 12 months. Tacrolimus, glucocorticoid and antibody induction can be treated according to the clinical routine diagnosis and treatment path, and no specific restrictions were made in this study
- Conditions
- Kidney Transplant Rejection
- Being tested
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Keywords
- EC-MPS, Kidney Transplant Rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-Coated Mycophenolate Sodium (EC-MPS)Drug
The recommended dose range is 360 to 720mg,bid
| Study group | Role | What they receive |
|---|---|---|
| Imitation EC-MPS(Ruiyirong) | Experimental | Not described Receives: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
| Original EC-MPS（myfortic） | Active comparator | Not described Receives: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute rejection
Measured: 6 months after renal transplantation
Incidence of acute rejection
Measured: 12 months after renal transplantation
Secondary outcomes (1)
Incidence of gastrointestinal reactions
Measured: 12 months after renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhishui Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhishui Chen, Tongji Hospital
- Investigators
- Zhishui Chen, Dr., Principal investigator, Tongji Hospital Wuhan, Hubei, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872568
- Sponsor's protocol ID
- TransMate001
- Status last verified
- May 2023
- First submitted
- 23 Mar 2023
- Last updated
- 24 May 2023
- 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients：A Large, Multiple-Center Prospective Study
- ClinicalTrials.gov ID
- NCT05872568
- Acronym / sponsor ID
- TransMate001
- Conditions
- Kidney Transplant Rejection
- Keywords
- EC-MPS, Kidney Transplant Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Zhishui ChenUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 May 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.
At present, imitation EC-MPS have just come on the market, no clinical studies have confirmed the efficacy and safety of using imitation EC-MPS for immunosuppressive therapy after kidney transplantation. Therefore, there is an urgent need to conduct a multicenter study in China to provide further guidance for the use of imitated mycophenol sodium enteric-coated tablets in kidney transplant patients. Therefore, this study will analyze whether the anti-rejection effect of generic EC-MPS in the treatment of renal transplantation in Chinese population is equivalent to that of the original EC-MPS, in order to provide reference for clinical rational drug use.
Detailed description
Under the premise that tacrolimus is used as basic immunosuppressant, to explore the efficacy and safety of imitation mecophenol sodium enteric-coated tablets (EC-MPS) compared with the original preparation agent (Miv) in Chinese kidney transplant patients.
This study was divided into experimental group and control group. The experimental group was imitation mycophenol sodium enteric-coated tablets, and the control group was original mycophenol sodium enteric-coated tablets. Both groups were treated with the triple immunosuppressive regimen of "Mycopherol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" immediately after transplantation for at least 12 months. Tacrolimus, glucocorticoid and antibody induction can be treated according to the clinical routine diagnosis and treatment path, and no specific restrictions were made in this study
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imitation EC-MPS(Ruiyirong) | Experimental | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
| Original EC-MPS（myfortic） | Active comparator | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female, aged 18-65;
- Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time;
- After kidney transplantation, patients were subjected to a routine triple immunosuppressive regimen, namely "mecophenol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" regimen;
- The patients signed informed consent, were able to follow up regularly and fully collect information related to this study.
Key exclusion criteria (9 listed)
- Multi-organ recipients, such as those with heart, lung, liver and other organ transplants;
- ABO incompatible kidney transplant recipients;
- HLA antibodies or past/current population reactive antibody level (PRA) > 25% were preexisting in the recipient before renal transplantation;
- Allergic to EC-MPS or preparation components (hypersensitivity);
- Women with fertility potential who are pregnant, lactating or planning to become pregnant;
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 |
|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS)The recommended dose range is 360 to 720mg,bid | Drug | Imitation EC-MPS(Ruiyirong), Original EC-MPS（myfortic） |
Primary outcome
Incidence of acute rejection
Time frame: 6 months after renal transplantation
Incidence of acute rejection
Time frame: 12 months after renal transplantation
1 secondary outcome
Incidence of gastrointestinal reactions
Time frame: 12 months after renal transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- 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.
Zhishui Chen, Dr. principal investigator
Tongji Hospital Wuhan, Hubei, China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) in people with Kidney Transplant Rejection, run by Zhishui Chen.
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 9 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Song Chen, Dr. (13971169862 ext. 86, schen@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute rejection (time frame: 6 months after renal transplantation). The study lists 2 primary outcomes in all. 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 24 May 2023.