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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

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

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Song Chen, Dr.; Phone Number: 86 13971169862; Email: schen@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imitation EC-MPS(Ruiyirong)	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS); The recommended dose range is 360 to 720mg,bid
Active Comparator: Original EC-MPS（myfortic）	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS); The recommended dose range is 360 to 720mg,bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of acute rejection	6 months after renal transplantation
Incidence of acute rejection	12 months after renal transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of gastrointestinal reactions	12 months after renal transplantation

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Zhishui Chen
• Investigators: Principal Investigator: Zhishui Chen, Dr., Tongji Hospital Wuhan, Hubei, China

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: EC-MPS; Kidney Transplant Rejection
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: TransMate001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No