Blood Level Monitoring of Mycophenolate Mofetil in People With Lupus Nephritis
Tests whether checking mycophenolic acid blood levels helps kidney remission in lupus nephritis.
Plain-language title generated from the registry record
Registry title: Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis
Key facts
- Where
- São Luís, BrazilSee the site
Where in Brazil
- University Hospital of the Federal University of MaranhãoSão Luís, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Federal University of Maranhao
- Trial code
- NCT07493655
- Record updated
- 25 March 2026
- Original description
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.Read full original descriptionShow less
Impact of Therapeutic Drug Monitoring of Mycophenolate Mofetil in Patients With Lupus Nephritis: A Randomized Clinical Trial
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.
Inclusion: 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.
Exclusion: Use of investigational drugs; Concomitant use of drugs that strongly modify pharmacokinetics (PK) without the possibility of adjustment, such as rifampicin; 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.