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A Single-center, Single-arm Clinical Study of the Efficacy and Safety of Conversion of Mycophenolate Mofetil to Mycophenolate Sodium Enteric-Coated Tablets in Stable Phase of Kidney Transplant Recipients

A Single-center, Single-arm Clinical Study of the Efficacy and Safety of Conversion of Mycophenolate Mofetil to Mycophenolate Sodium Enteric-Coated Tablets in Stable Phase of Kidney Transplant Recipients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091632
Enrollment
Unknown
Registered
2024-10-31
Start date
2024-01-25
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplant

Interventions

EC-MPS + tacrolimus + glucocorticoids:At least 6 months after kidney transplantation, the recipients should be treated with MMF as an antimetabolite drug, and all were treated with a triple immunosupp

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Stable kidney transplant recipients who have received allogeneic for the first time (>= 6 months after kidney transplantation), regardless of age and gender; (2) Routine use of "MMF+tacrolimus (TAC)+glucocorticoid" triple immunosuppression regimen for at least 4 consecutive weeks before enrollment; (3) Patients who need to stop MMF due to gastrointestinal adverse reactions or investigator evaluation, change to domestic EC-MPS (Reyirong) and plan to use it continuously for at least 1 year;

Exclusion criteria

Exclusion criteria: (1) Multi-organ recipients, such as those with heart, lung, liver and other organ transplants; (2) Those who are allergic to MPA, such as MMF, EC-MPS or preparation components (hypersensitivity); (3) Women who are pregnant, lactating or planning to become pregnant; (4) severe/uncontrolled concomitant infections or other serious medical problems; (5) Active bacterial, viral, or fungal infection; (6) Neutropenia (ANC <1.3×10^3/µL) (7) Patients who are judged by the investigator to be unsuitable for inclusion in this study for other reasons.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal symptom score;

Secondary

MeasureTime frame
Improvement of gastrointestinal reactions;Treatment failure rate;

Countries

China

Contacts

Public ContactXiaoming Ding

The First Affiliated Hospital of Xi'an Jiaotong University

xmding1970@163.com+86 139 9123 8632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026