Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis

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Conditions studied: Systemic Lupus Erythematosus, Lupus Nephritis, Drug Monitoring, Mycophenolic Acid

In brief

Systemic lupus erythematosus (SLE) is an inflammatory, chronic, and multisystem autoimmune disease characterized by periods of activity and remission. Lupus nephritis (LN) is the most frequent renal complication and is associated with high morbidity, manifesting as nephritic or nephrotic syndrome, complement consumption, and positivity for anti-double-stranded DNA antibodies. Mycophenolate mofetil (MMF) is an immunosuppressive agent that modifies the course of LN and is converted into mycophenolic acid (MPA), its measurable active metabolite. However, MMF exhibits complex interindividual and interethnic variability in metabolism, reinforcing the need for personalized strategies through therapeutic drug monitoring (TDM) to ensure renal remission. The objective of this study is to determine whether the implementation of MPA TDM results in a higher rate of renal remission over 12 months compared with standard treatment. This is a randomized, blinded clinical trial to be conducted at a teaching hospital in Maranhão over a 12-month period. From an estimated population of 187 eligible patients with LN receiving MMF, 100 consecutive participants will be randomized (50 per group). MPA monitoring will occur at three time points (T1, T2, T5), while clinical and laboratory outcome assessments will be performed quarterly (T1-T5). The primary outcome will be the renal remission rate; secondary outcomes include serum MPA levels, adverse events, hospitalizations, and medication adherence. This study will generate evidence on precision therapeutics applied to MMF in LN within the Brazilian public health system (SUS), particularly regarding the pilot use of TDM for dose optimization and maximization of clinical response.

Key facts

Study ID: NCT07493655
Run by: Federal University of Maranhao
People needed: 100
Starts: 2026-07-01
Expected to finish: 2028-12-31
Last updated by the study team: 2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged ≥18 years, of both sexes
Diagnosis of systemic lupus erythematosus (SLE) according to the ACR criteria, with at least four criteria present for the diagnosis of SLE, and active lupus nephritis (class III-V) documented by renal biopsy with histological classification within the last 6 months or presence of urine protein-to-creatinine ratio (UPCR > 0.5) or 24-hour proteinuria (>500 mg)
Use of mycophenolate mofetil (MMF) in the maintenance phase within the first 3 months
Residents of the municipalities of São Luís, São José de Ribamar, and Paço do Lumiar, located in the Metropolitan Region of Greater São Luís

You may not qualify if…

Individuals with contraindications to MMF (known hypersensitivity, pregnancy, or breastfeeding)
Active severe infection (e.g., tuberculosis, sepsis)
Unstable renal replacement therapy and severe hepatic failure
Use of investigational drugs
Concomitant use of drugs that strongly modify pharmacokinetics (PK) without the possibility of adjustment, such as rifampicin.

Where it is running

University Hospital of the Federal University of Maranhão — São Luís, Maranhão, Brazil

Full record on ClinicalTrials.gov

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