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Clinical Trial NCT07493655 (LUPUS-MONITOR) for Systemic Lupus Erythematosus, Lupus Nephritis, Drug Monitoring, Mycophenolic Acid is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis (LUPUS-MONITOR) 100 Randomized Personalized Treatment

Not yet recruiting
Clinical Trial NCT07493655 (LUPUS-MONITOR) is an interventional study for Systemic Lupus Erythematosus, Lupus Nephritis, Drug Monitoring, Mycophenolic Acid and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2026 and continue until the study accrues 100 participants. Led by Federal University of Maranhao, this study is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 immuno...

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Detailed Description
Randomized clinical trial, blinded to participants, to be conducted with patients treated at the Rheumatology Outpatient Clinic of the University Hospital of the Federal University of Maranhão (HU-UFMA) by a clinical pharmacist/researcher from the Clinical Pharmacy Unit (UFCLI) and a rheumatologist. The Clinical Research Center (CEPEC/UFMA) and the Clinical Analysis Laboratory of HU-UFMA will serve as reference sites...Show More
Official Title

Impact of Therapeutic Drug Monitoring of Mycophenolate Mofetil in Patients With Lupus Nephritis: A Randomized Clinical Trial

Conditions
Systemic Lupus ErythematosusLupus NephritisDrug MonitoringMycophenolic Acid
Other Study IDs
  • LUPUS-MONITOR
  • 94827126.0.0000.5086
NCT ID Number
NCT07493655
Start Date (Actual)
2026-07-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTDM-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 re...Show More
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
Active ComparatorControl 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 M...Show More
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Proportion of patients in renal remission
12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Trough MPA concentration (C0) over follow-up
Trough MPA concentration (C0)
12 months
adverse events
MMF-related adverse events
12 months
hospitalizations
Lupus nephritis-related hospitalizations
12 months
Medication adherence
Medication adherence (Brief Medication Questionnaire - BMQ) Adherent: patient with no positive responses in the three domains of the questionnaire (score = 0/ Adherent: BMQ = 0) Non-adherent (low adherence): ≥3 positive responses, indicating multiple barriers to the correct use of medications (BMQ ≥ 1).
12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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.
Federal University of Maranhao logoFederal University of Maranhao
Universidade Federal de Alfenas logoUniversidade Federal de Alfenas
Study Responsible Party
Elayne Costa da Silva, Principal Investigator, Principal Investigator, Federal University of Maranhao
Study Central Contact
Contact: Elayne E Costa da Silva, +55 98 21091280, [email protected]
1 Study Locations in 1 Countries

Maranhão

University Hospital of the Federal University of Maranhão, São Luís, Maranhão, 65020-070, Brazil
Elayne Costa da Silva, Contact, +55982109-1280, [email protected]
Elayne Costa, Principal Investigator
Rodrigo Mendonça, Sub-Investigator
Vanessa Bergamin, Sub-Investigator
Andrea Fontenelle, Sub-Investigator