Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis

Conditions

• Drug Monitoring
• Lupus Nephritis
• Mycophenolic Acid
• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Therapeutic Drug Monitoring — OTHER
  The serum MPA (C0) concentration will be measured at three time points (T1, T2, and T5). Between these visits, outpatient clinical assessments (T1 and T5) will be conducted without bioanalytical MPA sampling, allowing for continuous clinical follow-up with reduced participant burden and optimized resource utilization
• Standard clinical care — OTHER
  The participant will be receiving MMF according to the Ministry of Health protocol for lupus nephritis, with quarterly clinical assessments (T1-T5) conducted without therapeutic drug monitoring of MPA.

Study Details

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 Dates

First listed

Mar 25, 2026

Start date

Jul 1, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: TDM-guided
  Serum MPA (C0) measurement will be performed at three time points (T1, T2, and T5). Between these visits, outpatient clinical evaluations (T1 to T5) will be conducted without bioanalytical MPA collection, allowing continuous clinical follow-up with reduced participant burden and optimized resource use. Will be evaluated complete clinical remission of lupus nephritis (LN) or target renal response, partial clinical remission of LN, and lack of response, measured by 24-hour proteinuria and urinary protein-to-creatinine ratio e MPA concentration (C0) throughout follow-up (T1, T2, T5), Adverse events related to MMF, Hospitalizations related to lupus nephritis and Medication adherence.
• Active Comparator: Control group
  Participants will receive MMF according to the Brazilian Ministry of Health protocol for lupus nephritis, with quarterly clinical evaluations (T1-T5) and no therapeutic drug monitoring of MPA. Will be evaluated complete clinical remission of lupus nephritis (LN) or target renal response, partial clinical remission of LN, and lack of response, measured by 24-hour proteinuria and urinary protein-to-creatinine ratio e MPA concentration (C0) throughout follow-up (T1, T2, T5), Adverse events related to MMF, Hospitalizations related to lupus nephritis and Medication adherence.

Primary Outcome Measure

Proportion of patients in renal remission [ Time Frame: 12 months ]

Central Contacts

• Elayne E Costa da Silva
  +55 98 21091280
  [email protected]

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