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

NCT ID: NCT05872568

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-12-31

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

Conditions

Kidney Transplant Rejection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Imitation EC-MPS(Ruiyirong)

Group Type: EXPERIMENTAL

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Intervention Type: DRUG

The recommended dose range is 360 to 720mg,bid

Original EC-MPS（myfortic）

Group Type: ACTIVE_COMPARATOR

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Intervention Type: DRUG

The recommended dose range is 360 to 720mg,bid

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)

The recommended dose range is 360 to 720mg,bid

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhishui Chen

OTHER

Sponsor Role: lead

Responsible Party

Zhishui Chen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhishui Chen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital Wuhan, Hubei, China

Central Contacts

Song Chen, Dr.

Role: CONTACT

schen@tjh.tjmu.edu.cn

13971169862 ext. 86

Other Identifiers

TransMate001

Identifier Type: -

Identifier Source: org_study_id