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临床试验 NCT07493655 (LUPUS-MONITOR) 针对系统性红斑狼疮，狼疮性肾炎，药物监测，Mycophenolic Acid目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis (LUPUS-MONITOR) 100 随机化 个性化治疗
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临床试验NCT07493655 (LUPUS-MONITOR)是一项针对系统性红斑狼疮，狼疮性肾炎，药物监测，Mycophenolic Acid的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年7月1日开始，预计招募100名患者。该研究由Federal University of Maranhao主导，计划于2028年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月25日。
简要概括
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...
显示更多详细描述
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...显示更多
官方标题
Impact of Therapeutic Drug Monitoring of Mycophenolate Mofetil in Patients With Lupus Nephritis: A Randomized Clinical Trial
疾病
系统性红斑狼疮狼疮性肾炎药物监测Mycophenolic Acid其他研究标识符
- LUPUS-MONITOR
- 94827126.0.0000.5086
NCT编号
实际开始日期
2026-07-01
最近更新发布
2026-03-25
预计完成日期
2028-12-31
计划入组人数
100
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
主要目的
治疗方法
分配方式
随机
干预模型
序贯设计
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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 re...显示更多 | 治疗药物监测 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 |
阳性对照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 M...显示更多 | 标准临床护理 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. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Proportion of patients in renal remission | 12 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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 MaranhaoUniversidade Federal de Alfenas研究责任方
Elayne Costa da Silva, 主要研究者, Principal Investigator, Federal University of Maranhao
研究中心联系人
联系人: Elayne E Costa da Silva, +55 98 21091280, [email protected]
1 位于 1 个国家/地区的研究中心
Maranhão
University Hospital of the Federal University of Maranhão, São Luís, Maranhão, 65020-070, Brazil
Elayne Costa da Silva, 联系人, +55982109-1280, [email protected]
Elayne Costa, 主要研究者
Rodrigo Mendonça, 分研究者
Vanessa Bergamin, 分研究者
Andrea Fontenelle, 分研究者