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Studies on PK/PD variability and individualized administration of mycophenolic acid in patients with lupus nephritis based on a population-based approach

Studies on PK/PD variability and individualized administration of mycophenolic acid in patients with lupus nephritis based on a population-based approach

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086506
Enrollment
Unknown
Registered
2024-07-03
Start date
2024-07-10
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

lupus nephritis

Interventions

Induction therapy group (Mycophenolate mofetil (MMF), po, 1.5 to 2 g per day):None
Maintenance treatment group (Mycophenolate mofetil (MMF), po, 0.5 to 1.5 g per day):None

Sponsors

Guizhou Provincial People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects with lupus nephritis (LN) who were diagnosed according to Chinese guidelines for the diagnosis and treatment of LN; 2. Subjects who were aged over years old; 3. Subjects who need to receive mycophenolate mofetil (MMF) after evaluation by specialized clinicians; 4. Subjects who could fully understand the content of the trial and sign the informed consent form themselves or their legal representatives.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Subjects with malignant tumor; 3. Subjects with severe gastrointestinal dysfunction.

Design outcomes

Secondary

MeasureTime frame
Remission/relapse;Disease activity;Organ damage;

Primary

MeasureTime frame
Exposure of mycophenolic acid (MPA);Activity of inosine 5’-monophosphate dehydrogenase (IMPDH);

Countries

China

Contacts

Public ContactSheng Changcheng

Guizhou Provincial People’s Hospital

9921532@qq.com+86 181 9826 1601

Outcome results

None listed

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