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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhishui Chen
• Treatments: Mycophenolic Acid

Criteria

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.