Charite University, Berlin, Germany — Biomedical Watch V2

Traitements8programmes

Essais4liés

Publications8liées

SourceDBlocale

Traitements

8

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Daratumumab InjectionThis is a monocenter, open-label Phase II trial for refractory SLE patients currently on stable background immunosuppressive therapy. Treatment in this trial will be daratumumab weekly for a period of 8 weeks. This study will enroll 10 patients.	Lupus	Phase 2	À vérifier		À vérifier
Epigallocatechin-GallateEGCG has shown a neuroprotective effect in cell-experimental and animal studies. The neuroprotective mechanism of EGCG probably bases - besides the known antioxidant effect - amongst others on the modulation of several signal transduction pathways, the influence on the expression of genes which regulate cell survival resp. programmed cell death, as well as the modulation of the mitochondrial function. In different Alzheimer models EGCG seems to cause an induction of alpha-secretase and the endothelin-converting-enzyme, as well as to prevent the aggregation of beta-amyloid to toxic oligomers through the direct binding to the unfolded peptide. The investigators therefore expect EGCG to have a positive influence on the course of the Alzheimer´s Disease.	Alzheimer	Phase 2/3	Neuroprotection + Remyélinisation indirecte / réparation	Germany	À vérifier
Predicting Cognition After DBS for Parkinson's Disease 2The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management and personalize therapeutic strategies for optimal long-term benefit. The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.	Parkinson	À vérifier	À vérifier	Germany	À vérifier
Urinary T Cell Biomarker for Prediction in Lupus NephritisUrinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. In a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). Treatment will be performed to the discretion of the treating clinician. After 6 months of treatment response will be determined as either complete response or partial response.	Lupus	À vérifier	Immunomodulation	Germany, United Kingdom	À vérifier
Daratumumab InjectionThis is a monocenter, open-label Phase II trial for refractory SLE patients currently on stable background immunosuppressive therapy. Treatment in this trial will be daratumumab weekly for a period of 8 weeks. This study will enroll 10 patients.	Lupus	Phase 2	À vérifier		À vérifier
Urinary T Cell Biomarker for Prediction in Lupus NephritisUrinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. In a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). Treatment will be performed to the discretion of the treating clinician. After 6 months of treatment response will be determined as either complete response or partial response.	Lupus	À vérifier	Immunomodulation	Germany, United Kingdom	À vérifier
Epigallocatechin-GallateEGCG has shown a neuroprotective effect in cell-experimental and animal studies. The neuroprotective mechanism of EGCG probably bases - besides the known antioxidant effect - amongst others on the modulation of several signal transduction pathways, the influence on the expression of genes which regulate cell survival resp. programmed cell death, as well as the modulation of the mitochondrial function. In different Alzheimer models EGCG seems to cause an induction of alpha-secretase and the endothelin-converting-enzyme, as well as to prevent the aggregation of beta-amyloid to toxic oligomers through the direct binding to the unfolded peptide. The investigators therefore expect EGCG to have a positive influence on the course of the Alzheimer´s Disease.	Alzheimer	Phase 2/3	Neuroprotection + Remyélinisation indirecte / réparation	Germany	À vérifier
Predicting Cognition After DBS for Parkinson's Disease 2The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management and personalize therapeutic strategies for optimal long-term benefit. The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.	Parkinson	À vérifier	À vérifier	Germany	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
Predicting Cognition After DBS for Parkinson's Disease 2	Parkinson	À vérifier	NCT06272968	Predicting Cognition After DBS for Parkinson's Disease 2	ACTIVE_NOT_RECRUITING
Epigallocatechin-Gallate	Alzheimer	Phase 2/3	NCT00951834	SUN-AK — Sunphenon EGCg (Epigallocatechin-Gallate) in the Early Stage of Alzheimer´s Disease	COMPLETED
Urinary T Cell Biomarker for Prediction in Lupus Nephritis	Lupus	À vérifier	NCT04320797	Urinary T Cell Biomarker for Prediction in Lupus Nephritis	UNKNOWN
Daratumumab Injection	Lupus	Phase 2	NCT04810754	An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus	UNKNOWN

Publications

8

Molécule	Indication / population	Titre	Journal	Date
Urinary T Cell Biomarker for Prediction in Lupus Nephritis		A stronger type I interferon signature distinguishes ANCA-associated vasculitis phenotypes and predicts kidney prognosis.	Kidney international
Urinary T Cell Biomarker for Prediction in Lupus Nephritis		Deep profiling of lupus nephritis kidneys reveals dynamic changes in myeloid cells associated with disease progression.	Annals of the rheumatic diseases
Urinary T Cell Biomarker for Prediction in Lupus Nephritis		Serum sPD-1 and sTIM-3 as T-cell exhaustion biomarkers in systemic lupus erythematosus: the IL-6-associated exhaustion axis and the SLE Immune Exhaustion Index.	Human immunology
Daratumumab Injection		Anti-CD38/Anti-CD20 Rescue Therapy for Posttransplant Recurrent FSGS.	Kidney international reports
Daratumumab Injection		Comparison of Non-sedating and Sedating Histamine H-receptor Antagonist Premedication for Preventing Subcutaneous Daratumumab-associated Infusion-related Reactions: A Multicenter Retrospective Observational Study.	The Keio journal of medicine
Daratumumab Injection		Transitioning Therapeutic Antibodies in Oncology from Intravenous to Hyaluronidase-Facilitated Subcutaneous Administration.	Clinical pharmacokinetics
Daratumumab Injection		CD38 overexpression drives glioblastoma progression via L1CAM/ICAM1/JAK-STAT-Driven tumor microenvironment rewiring.	Translational oncology
Daratumumab Injection		Safety and Effectiveness of Daratumumab in Recurrent and De Novo Focal Segmental Glomerulosclerosis After Kidney Transplant.	Kidney medicine