Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients：A Large, Multiple-Center Prospective Study

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imitation EC-MPS(Ruiyirong)<br> | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)<br>* The recommended dose range is 360 to 720mg,bid<br>|
| Active Comparator: Original EC-MPS（myfortic）<br> | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)<br>* The recommended dose range is 360 to 720mg,bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejection |  | 6 months after renal transplantation | 
| Incidence of acute rejection |  | 12 months after renal transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of gastrointestinal reactions |  | 12 months after renal transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EC-MPS, Kidney Transplant Rejection