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

NCT05872568 | Unknown Phase 4

• 1 other identifier: TransMate001
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Transplant Rejection

Keywords

EC-MPS; Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (2)

• Incidence of acute rejection

  6 months after renal transplantation

• Incidence of acute rejection

  12 months after renal transplantation

Secondary Outcomes (1)

• Incidence of gastrointestinal reactions

  12 months after renal transplantation

Other Outcomes (3)

• Graft survival rate

  12 months after renal transplantation

• Patients survival rate

  12 months after renal transplantation

• adverse event rate

  12 months after renal transplantation

Study Arms (2)

Imitation EC-MPS(Ruiyirong)

EXPERIMENTAL

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Original EC-MPS（myfortic）

ACTIVE COMPARATOR

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS) DRUG

The recommended dose range is 360 to 720mg,bid

Imitation EC-MPS(Ruiyirong); Original EC-MPS（myfortic）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, aged 18-65;
• Patients with end-stage renal disease who received live/cadaveric kidney transplantation for the first time;
• After kidney transplantation, patients were subjected to a routine triple immunosuppressive regimen, namely "mecophenol sodium enteric-coated tablets (EC-MPS) + tacrolimus (TAC) + glucocorticoid" regimen;
• The patients signed informed consent, were able to follow up regularly and fully collect information related to this study.

You may not qualify if:

• Multi-organ recipients, such as those with heart, lung, liver and other organ transplants;
• ABO incompatible kidney transplant recipients;
• HLA antibodies or past/current population reactive antibody level (PRA) \> 25% were preexisting in the recipient before renal transplantation;
• Allergic to EC-MPS or preparation components (hypersensitivity);
• Women with fertility potential who are pregnant, lactating or planning to become pregnant;
• Severe/uncontrolled concomitant infections or other serious medical problems;
• Active bacterial, viral or fungal infections;
• Neutropenia (ANC\<1.3×103/µL)

Sponsors & Collaborators

• Zhishui Chen: lead

Study Officials

• Zhishui Chen, Dr.

  Tongji Hospital Wuhan, Hubei, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Chen, Dr.

CONTACT

13971169862; schen@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 24, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share