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Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis

NCT07493655 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Therapeutic Drug Monitoring

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

OTHER

Standard clinical care

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.

Sponsors & Collaborators

  • Universidade Federal de Alfenas

    collaborator OTHER

  • Federal University of Maranhao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07493655 on ClinicalTrials.gov