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治験 NCT07493655 (LUPUS-MONITOR)（対象：全身性エリテマトーデス、ループス腎炎、薬物モニタリング、Mycophenolic Acid）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis (LUPUS-MONITOR) 100 無作為化 個別化医療
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07493655 (LUPUS-MONITOR) は 介入研究 臨床試験 で、全身性エリテマトーデス、ループス腎炎、薬物モニタリング、Mycophenolic Acid に関するものです。現在は 募集準備中 で、2026年7月1日 に開始予定です。100 名の参加者 の募集が計画されています。この試験は Federal University of Maranhao によって主導され、2028年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月25日 です。
概要
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...
もっと見る詳細説明
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...もっと見る
公式タイトル
Impact of Therapeutic Drug Monitoring of Mycophenolate Mofetil in Patients With Lupus Nephritis: A Randomized Clinical Trial
疾患名
全身性エリテマトーデスループス腎炎薬物モニタリングMycophenolic Acidその他の研究識別子
- LUPUS-MONITOR
- 94827126.0.0000.5086
主目的
治療
割付方法
無作為化
介入モデル
逐次割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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...もっと見る | 治療薬モニタリング 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 |
実薬対照薬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...もっと見る | 標準臨床ケア 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. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Proportion of patients in renal remission | 12 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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責任者
Elayne Costa da Silva, 主任研究者, Principal Investigator, Federal University of Maranhao
試験中央連絡先
連絡先: Elayne E Costa da Silva, +55 98 21091280, [email protected]
1 1カ国の場所
Maranhão
University Hospital of the Federal University of Maranhão, São Luís, Maranhão, 65020-070, Brazil
Elayne Costa da Silva, 連絡先, +55982109-1280, [email protected]
Elayne Costa, 主任研究者
Rodrigo Mendonça, 副研究者
Vanessa Bergamin, 副研究者
Andrea Fontenelle, 副研究者