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

TransMate001

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.

2023-06-01

2025-12-31

2025-12-31

Not yet recruiting

Early phase I

270

Inclusion Criteria: 1. Male and female, aged 18-65; 2. Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time; 3. After kidney transplantation, patients were subjected to a routine triple immunosuppressive regimen, namely "mecophenol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" regimen; 4. The patients signed informed consent, were able to follow up regularly and fully collect information related to this study. Exclusion Criteria: 1. Multi-organ recipients, such as those with heart, lung, liver and other organ transplants; 2. ABO incompatible kidney transplant recipients; 3. HLA antibodies or past/current population reactive antibody level (PRA) \> 25% were preexisting in the recipient before renal transplantation; 4. Allergic to EC-MPS or preparation components (hypersensitivity); 5. Women with fertility potential who are pregnant, lactating or planning to become pregnant; 6. Severe/uncontrolled concomitant infections or other serious medical problems; 7. Active bacterial, viral or fungal infections; 8. Neutropenia (ANC\<1.3×103/µL) 9. Patients judged by the investigator to be unsuitable for inclusion in this study for other reasons.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 270, 'type': 'ESTIMATED'}}

2023-05-24