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

NCT05872568 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2023-05-24

No results posted yet for this study

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

Interventions

DRUG

Enteric-Coated Mycophenolate Sodium (EC-MPS)

The recommended dose range is 360 to 720mg,bid

Sponsors & Collaborators

  • Zhishui Chen

    lead OTHER

Principal Investigators

  • Zhishui Chen, Dr. · Tongji Hospital Wuhan, Hubei, China

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872568 on ClinicalTrials.gov