Clinical Research Directory

Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis

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 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. The 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. This 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). MPA 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. This 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.

Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients

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.

TDM Guided Early Optimization of ADAL in Crohn's Disease

To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.

Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

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.

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

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/Ml (arm A) with standard of care (arm B).