Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — Biomedical Watch V2

Traitements4programmes

Essais3liés

Publications7liées

SourceDBlocale

Traitements

4

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Mycophenolate Mofetil (MMF) TreatmentThe goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE). It will also investigate whether early changes in kidney tissue can predict long-term treatment response and whether blood or urine biomarkers can be used to monitor disease activity without the need for repeat kidney biopsies. The main questions it aims to answer are: * Does adding voclosporin to standard treatment with mycophenolate mofetil (MMF) and prednisolone result in greater early improvement of kidney inflammation compared with MMF and prednisolone alone? * Are specific macrophage and monocyte populations associated with treatment response and long-term kidney outcomes? * Can blood- or urine-based biomarkers be identified that reflect kidney inflammation and treatment response? Researchers will compare MMF, prednisolone, and voclosporin (triple therapy) with MMF and prednisolone alone (dual therapy) to determine whether intensified treatment leads to faster and more complete immunological and histological remission. Participants with newly diagnosed or relapsing proliferative lupus nephritis will: * Be randomly assigned to receive either triple therapy (MMF, prednisolone, and voclosporin) or dual therapy (MMF and prednisolone). * Undergo a kidney biopsy before treatment starts and a repeat kidney biopsy after 3 months of treatment. * Provide blood and urine samples during follow-up for immune cell analyses and biomarker studies. * Complete patient-reported outcomes questionnaires * Attend regular study visits and clinical assessments for up to 2 years. In addition, participants with SLE without lupus nephritis and healthy volunteers will provide blood samples to allow comparison of circulating immune cell populations between groups.	Lupus	Phase 4	Immunomodulation	Netherlands	À vérifier
Nano KnifeBackground: Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system. The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of this new technology. Primary Objectives: * To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour. * To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events. Secondary Objectives: * To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. * To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. Population: 10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy. Intervention: Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.	Cancer	Phase 1/2	À vérifier	Netherlands	À vérifier
Voclosporin (LUPKYNIS)The goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE). It will also investigate whether early changes in kidney tissue can predict long-term treatment response and whether blood or urine biomarkers can be used to monitor disease activity without the need for repeat kidney biopsies. The main questions it aims to answer are: * Does adding voclosporin to standard treatment with mycophenolate mofetil (MMF) and prednisolone result in greater early improvement of kidney inflammation compared with MMF and prednisolone alone? * Are specific macrophage and monocyte populations associated with treatment response and long-term kidney outcomes? * Can blood- or urine-based biomarkers be identified that reflect kidney inflammation and treatment response? Researchers will compare MMF, prednisolone, and voclosporin (triple therapy) with MMF and prednisolone alone (dual therapy) to determine whether intensified treatment leads to faster and more complete immunological and histological remission. Participants with newly diagnosed or relapsing proliferative lupus nephritis will: * Be randomly assigned to receive either triple therapy (MMF, prednisolone, and voclosporin) or dual therapy (MMF and prednisolone). * Undergo a kidney biopsy before treatment starts and a repeat kidney biopsy after 3 months of treatment. * Provide blood and urine samples during follow-up for immune cell analyses and biomarker studies. * Complete patient-reported outcomes questionnaires * Attend regular study visits and clinical assessments for up to 2 years. In addition, participants with SLE without lupus nephritis and healthy volunteers will provide blood samples to allow comparison of circulating immune cell populations between groups.	Lupus	Phase 4	Immunomodulation	Netherlands	À vérifier
Nano KnifeBackground: Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system. The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of this new technology. Primary Objectives: * To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour. * To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events. Secondary Objectives: * To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. * To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. Population: 10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy. Intervention: Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.	Cancer	Phase 1/2	À vérifier	Netherlands	À vérifier

Essais cliniques

3

Molécule	Indication / population	Phase	NCT	Titre	Statut
Nano Knife	Cancer	Phase 1/2	NCT02298608	Efficacy and Safety of IRE for RMs	UNKNOWN
Kidney Biopsy	Lupus	Phase 4	NCT07760480	MAPLE — Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone	RECRUITING
Botulinum toxin type A	Migraine	Phase 4	NCT06448676	Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides	RECRUITING

Publications

7

Molécule	Indication / population	Titre	Journal	Date
Mycophenolate Mofetil (MMF) Treatment		Temporary mycophenolate discontinuation and reintroduction in pediatric kidney transplantation: predictors and long-term outcomes.	Pediatric nephrology (Berlin, Germany)
Mycophenolate Mofetil (MMF) Treatment		Outcomes and Predictors of Treatment Response in Patients With Pure Lupus Membranous Nephropathy.	Kidney international reports
Nano Knife		Insulation-tipped nano knife-assisted primary precut versus conventional cannulation for biliary access: a multicenter randomized trial on efficacy and safety.	Surgical endoscopy
Nano Knife		Exploring the Antimicrobial Potential of Vanadium-Based MXenes for Biomedical Applications.	MicrobiologyOpen
Nano Knife		Cuttlefish Ink-Derived Melanin/MXene Composites: Boosting Stability and Unleashing Synergistic Photothermal-Mechanical Antimicrobial Effects Against Biofilms.	Small (Weinheim an der Bergstrasse, Germany)
Mycophenolate Mofetil (MMF) Treatment		Bilateral Mooren's Ulcer With Corneal Perforation in Two Women of Different Ethnicities: A Report of Two Cases.	Cureus
Voclosporin (LUPKYNIS)		Network meta-analysis of triple immunosuppressive therapies and standard of care for induction of remission of active lupus nephritis.	Lupus