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A real-world, non-intervention, prospective study about the exposure of mycophenolic acid on safety and efficacy in patients with system lupus erythematosus

A real-world, non-intervention, prospective study about the exposure of mycophenolic acid on safety and efficacy in patients with system lupus erythematosus

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077840
Enrollment
Unknown
Registered
2023-11-21
Start date
2021-12-03
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

System lupus erythematosus

Interventions

Observation group:None

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? =18 years old; ? SLE patients who meet the classification criteria of SLE and seek treatment in our center; ? The oral dose of MMF was maintained for =5 days, and the dose of MMF was not adjusted in the past 4 weeks; ? Regular follow-up was conducted every 1 month, and the serum concentration of MPA was detected every 3 months, and the metabolic curve of AUC could be fitted successfully.

Exclusion criteria

Exclusion criteria: ? No regular follow-up, incomplete medical records; ? Other immunosuppressants, such as cyclosporine, tacrolimus, or biologics, such as rituximab, were used in the past six months; ? Kidney replacement therapy (RRT) is being used; ? Patients with severe liver disease; (5) Patients with poor compliance; (6) Recently combined with Sevelam, cholestyramine, rifampicin ± antiviral drugs have significant interaction; ? Patients with mental illness; Pregnancy and lactation; ? Other conditions that may interfere with patient comprehension or compliance.

Design outcomes

Primary

MeasureTime frame
Plasma concentration of MPA;

Secondary

MeasureTime frame
SLE2000;

Countries

China

Contacts

Public ContactXuepeng Gong

Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology

1020947167@qq.com+86 27 8366 3643

Outcome results

None listed

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