Kidney Transplant Rejection
Conditions
Keywords
EC-MPS, Kidney Transplant Rejection
Brief 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. 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
Interventions
DRUGEnteric-Coated Mycophenolate Sodium (EC-MPS)
The recommended dose range is 360 to 720mg,bid
Sponsors
Zhishui Chen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute rejection | 6 months after renal transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of gastrointestinal reactions | 12 months after renal transplantation |
Other
| Measure | Time frame |
|---|---|
| Graft survival rate | 12 months after renal transplantation |
| Patients survival rate | 12 months after renal transplantation |
| adverse event rate | 12 months after renal transplantation |
Contacts
Primary ContactSong Chen, Dr.
Outcome results
None listed