Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis

NCT07493655 | Not Yet Recruiting

• 1 other identifier: 94827126.0.0000.5086
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in renal remission

  12 months

Secondary Outcomes (4)

• Trough MPA concentration (C0) over follow-up

  12 months

• adverse events

  12 months

• hospitalizations

  12 months

• Medication adherence

  12 months

Study Arms (2)

TDM-guided

EXPERIMENTAL

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.

Other: Therapeutic Drug Monitoring

Control group

ACTIVE COMPARATOR

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.

Other: Standard clinical care

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

TDM-guided

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Federal University of Maranhao: lead
• Universidade Federal de Alfenas: collaborator

Study Sites (1)

University Hospital of the Federal University of Maranhão

São Luís, Maranhão, 65020-070, Brazil

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Elayne E Costa da Silva

CONTACT

+55 98 21091280; costa.elayne@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 25, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)