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

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05872568
• Other study ID #: TransMate001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Tongji Hospital
• Contact: Song Chen, Dr.
• Phone: 13971169862
• Email: schen[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Drug:
• Enteric-Coated Mycophenolate Sodium (EC-MPS)
The recommended dose range is 360 to 720mg,bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhishui Chen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Graft survival rate		12 months after renal transplantation
Other	Patients survival rate		12 months after renal transplantation
Other	adverse event rate		12 months after renal transplantation
Primary	Incidence of acute rejection		6 months after renal transplantation
Primary	Incidence of acute rejection		12 months after renal transplantation
Secondary	Incidence of gastrointestinal reactions		12 months after renal transplantation