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

• Sponsor: Zhishui Chen (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05872568
• Collaborator: (none)
• Enrollment: 270
• Arms: 2
• Anticipated Duration (Months): 31

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Rejection	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 270 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients：A Large, Multiple-Center Prospective Study
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of acute rejection [6 months after renal transplantation]

2. Incidence of acute rejection [12 months after renal transplantation]

Secondary Outcome Measures

1. Incidence of gastrointestinal reactions [12 months after renal transplantation]

Other Outcome Measures

1. Graft survival rate [12 months after renal transplantation]

2. Patients survival rate [12 months after renal transplantation]

3. adverse event rate [12 months after renal transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhishui Chen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhishui Chen, Professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT05872568
• Other Study ID Numbers: TransMate001
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhishui Chen, Professor, Tongji Hospital: EC-MPS; Kidney Transplant Rejection
• Additional relevant MeSH terms: Mycophenolic Acid

Study Results

No Results Posted as of May 24, 2023