NCT07493655Not yet recruiting
Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis
Impact of Therapeutic Drug Monitoring of Mycophenolate Mofetil in Patients With Lupus Nephritis: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 11 Mar 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Federal University of Maranhao
- Diseases
- Lupus (SLE)
- NCT number
- NCT07493655
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jul 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of investigational drugs
- Concomitant use of drugs that strongly modify pharmacokinetics (PK) without the possibility of adjustment, such as rifampicin.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of the Federal University of Maranhão Coordinator of this site? Confirm its status | São Luís | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.