[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-monitoring\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-monitoring":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,68,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630898","therapeutic-drug-monitoring-of-mycophenolate-mofetil-in-lupus-nephritis-100630898",false,"NCT07493655","Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis","Impact of Therapeutic Drug Monitoring of Mycophenolate Mofetil in Patients With Lupus Nephritis: A Randomized Clinical Trial","LUPUS-MONITOR","Inclusion criteria:\n\n* Adults aged ≥18 years, of both sexes\n* 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)\n* Use of mycophenolate mofetil (MMF) in the maintenance phase within the first 3 months\n* Residents of the municipalities of São Luís, São José de Ribamar, and Paço do Lumiar, located in the Metropolitan Region of Greater São Luís\n\nExclusion criteria:\n\n* Individuals with contraindications to MMF (known hypersensitivity, pregnancy, or breastfeeding)\n* Active severe infection (e.g., tuberculosis, sepsis)\n* Unstable renal replacement therapy and severe hepatic failure\n* Use of investigational drugs\n* Concomitant use of drugs that strongly modify pharmacokinetics (PK) without the possibility of adjustment, such as rifampicin.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nMycophenolate 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.\n\nThe 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.\n\nThis 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).\n\nMPA 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.\n\nThis 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.",[27,28,29,30],"Systemic Lupus Erythematosus","Lupus Nephritis","Drug Monitoring","Mycophenolic Acid","NOT_YET_RECRUITING","2026-03-23",{"date":34,"type":35},"2026-03-25","ACTUAL",{"date":37,"type":21},"2026-07-01",{"date":39,"type":21},"2028-12-31",{"name":41,"class":42},"Federal University of Maranhao","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100557990","microsampling-for-therapeutic-drug-monitoring-of-oral-oncolytics-in-oncology-patients-100557990","NCT06545292","Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients","Microsampling to Facilitate Drug Monitoring of Oncolytics","MSTDM","Inclusion Criteria:\n\n* Willing and able to provide informed consent;\n* 18 years of age or older;\n* Using one or more of the following drugs: Cabozantinib, Pazopanib, Sunitinib, Lenvatinib, Imatinib, Abiraterone, Enzalutamide, Nivolumab, Ipilimumab, Pembrolizumab, Atezolizumab, Bevacizumab or Enfortumab vedotin\n\nExclusion Criteria:\n\n* Not able to sample themselves using a finger prick","90 Years",{"count":54,"type":21},360,[24],"The aim of the study is to perform a clinical validation of the analytical method for dried blood spot microsampling of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin. The secondary objective is to test the feasibility of home monitoring (microsampling TDM) of cabozantinib, pazopanib, sunitinib, lenvatinib, imatinib, abiraterone, enzalutamide, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab or enfortumab vedotin in oncology patients.",[29],"RECRUITING","2025-11-18",{"date":61,"type":35},"2025-11-21",{"date":63,"type":35},"2025-10-06",{"date":65,"type":21},"2028-07-01",{"name":67,"class":42},"Leiden University Medical Center",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":43},"100548924","routinely-collected-clinical-data-and-evaluation-of-antimicrobial-target-attainment-100548924","NCT06427317","Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment","Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management","DATATDM","Inclusion Criteria:\n\n18 years of age or above.\n\n* Under follow-up for management of infection at Imperial College NHS Trust\n* Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).\n* Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):\n* Delirium which may be caused or exacerbated by having an infection.\n* Suspected\u002Fconfirmed central nervous system infection.\n* Critical illness requiring sedation and\u002For intubation and ventilation which is caused by or exacerbated by having an infection.\n\nExclusion Criteria:\n\n* Less than 18 years of age\n\n  * Severe anaemia (Hb \\\u003C 70g\u002Fl)\n  * Platelets \\\u003C 50x10\\^9\u002Fl, INR \\>1.5 or other known blood clotting impairment\n  * Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.\n  * Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.\n  * Patients with restricted liberty, prisoners or under legal protection.",{"count":77,"type":21},323,"OBSERVATIONAL","The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.",[81,82,29,83],"Infections, Bacterial","Pharmacokinetics","Drug-Related Side Effects and Adverse Reactions","2024-05-21",{"date":86,"type":35},"2024-05-23",{"date":88,"type":35},"2024-03-19",{"date":90,"type":21},"2027-03-19",{"name":92,"class":42},"Imperial College London",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100479619","phase-4-comparison-of-standard-dose-alectinib-to-alectinib-in-adjusted-dose-based-on-alectinib-bloodlevels-100479619","NCT05525338","Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels","Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing","ADAPT ALEC","Inclusion Criteria:\n\n* Patients with locally advanced or metastatic NSCLC (stage IIIB to stage IV by AJCC 8th)\n* ECOG performance status 0-4\n* Histologically or cytology confirmed NSCLC\n* Documented ALK rearrangement based on an EMA approved test\n* Patients can either be chemotherapy-naïve or have received one line of platinum-based chemotherapy\n* Patients with brain or leptomeningeal metastases are allowed on the study if the lesions are asymptomatic without neurological signs and clinically stable for at least 2 weeks without steroid treatment. Patients who do not meet these criteria are not eligible for the study\n* Measurable disease (by RECIST criteria version 1.1) prior to the first dose of study treatment\n* Signed writte Institutional Review Board (IRB)\u002FEthical Committee (EC) approved informed consent form, prior to performing any study-related procedures\n* Observational other studies are allwoed for patients included in this study\n* Local radiotherapy is allowed for pain\n\nExclusion Criteria:\n\n* Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug\n* Consumption of agents which modulate CYP3A4 or agents with potential QT prolonging effects within 14 days prior to admission and during the study (see concomitant medication restrictions)\n* Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the subject in this study.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and\u002For follow-up procedures; those conditions should be discussed with the patient before trial entry.",{"count":102,"type":21},196,[104],"PHASE4","The ADAPT ALEC randomized controlled trial (RCT) is performed in patients with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC). The RCT will compare the use of Therapeutic Drug Monitoring (TDM) and dose increases if alectinib 35 ng\u002FMl (arm A) with standard of care (arm B).",[29,107,108,109,110],"Carcinoma, Non-Small-Cell Lung","Lung Cancer","Anaplastic Lymphoma Kinase Gene Mutation","Anaplastic Lymphoma Kinase Gene Translocation",[112,113],"Alectinib","Randomized Controlled Trial","2024-05-10",{"date":116,"type":35},"2024-05-13",{"date":118,"type":35},"2022-03-23",{"date":120,"type":21},"2026-12-31",{"name":122,"class":42},"University Medical Center Groningen",8]