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O estudo clínico NCT07493655 (LUPUS-MONITOR) para Lúpus eritematoso sistêmico, Nefrite Lúpica, Monitorização de medicamentos, Mycophenolic Acid está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis (LUPUS-MONITOR) 100 Randomizado Personalizado

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07493655 (LUPUS-MONITOR) é um estudo intervencionista para Lúpus eritematoso sistêmico, Nefrite Lúpica, Monitorização de medicamentos, Mycophenolic Acid. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de julho de 2026, com o objetivo de incluir 100 participantes. Coordenado por Federal University of Maranhao e deve ser concluído em 31 de dezembro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de março de 2026.
Resumo
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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Descrição detalhada
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...Mostrar mais
Título oficial

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

Condições médicas
Lúpus eritematoso sistêmicoNefrite LúpicaMonitorização de medicamentosMycophenolic Acid
Outros IDs do estudo
  • LUPUS-MONITOR
  • 94827126.0.0000.5086
Número NCT
NCT07493655
Data de início (real)
2026-07-01
Última atualização postada
2026-03-25
Data de conclusão (estimada)
2028-12-31
Inscrição (estimada)
100
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Sequencial
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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...Mostrar mais
Monitoramento terapêutico de medicamentos
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
Comparador ativoControl 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...Mostrar mais
Cuidados clínicos padrão
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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Proportion of patients in renal remission
12 months
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • 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
Responsável pelo estudo
Elayne Costa da Silva, Investigador principal, Principal Investigator, Federal University of Maranhao
Contato central do estudo
Contato: Elayne E Costa da Silva, +55 98 21091280, [email protected]
1 Locais do estudo em 1 países

Maranhão

University Hospital of the Federal University of Maranhão, São Luís, Maranhão, 65020-070, Brazil
Elayne Costa da Silva, Contato, +55982109-1280, [email protected]
Elayne Costa, Investigador principal
Rodrigo Mendonça, Subinvestigador
Vanessa Bergamin, Subinvestigador
Andrea Fontenelle, Subinvestigador