Portal de recerca
Estudio de fase II, aleatorizado, doble ciego y controlado con placebo de búsqueda de dosis para evaluar la eficacia y la seguridad de ALXN2050 en participantes adultos con nefritis lúpica (NL) proliferativa o nefropatía por inmunoglobulina A (NIgA).
Dades bàsiques
- Protocol:
- ALXN2050-NEPH-201
- EURDRACT:
- 2021-001426-22
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2022
- Any de finalització:
- 2027
Objectius del projecte
Objetivo Principal: Evaluar la eficacia de ALXN2050 para reducir la proteinuria en participantes con NL o NIgA. Objetivos Secundarios: •Evaluar la eficacia de ALXN2050 para mejorar las mediciones de la función renal en participantes con NL o NIgA. •FC/FD- Caracterizar la farmacocinética (FC) y la farmacodinámica (FD) de ALXN2050 en participantes con NL o NIgA. •Seguridad- Caracterizar la seguridad y la tolerabilidad de ALXN2050 en participantes con NL o NIgA. Solo cohorte de NL •Evaluar la eficacia de ALXN2050 sobre las mediciones de la función renal en participantes con NL. Solo cohorte de NIgA •Evaluar la eficacia de ALXN2050 sobre las mediciones de la función renal en participantes con NIgA.
Documents
- No hi ha documents
Participants
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.
Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.12.007. 2025
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.
Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda
Article. 10.1016/j.farma.2024.09.006. 2024
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
Acquired perforating dermatosis in patients on peritoneal dialysis: a report of 3 cases.
Viejo-Boyano, Iris; (...); Hernandez-Jaras, Julio
Case Reports. 10.21037/acr-23-9. 2023
AN INCREASE OF FREE FATTY ACIDS ON PATIENTS STARTING PERITONEAL DIALYSIS SUGGESTS AN INCREASED CARDIOVASCULAR RISK BEYOND CLASSICAL DYSLIPIDEMIA BIOMARKERS
Lopez Romero, Luis Carlos; (...); Julia Hernández Lluesa
Meeting Abstract. 2022
ASSESSING THE EFFECTIVENESS OF LONG-TERM BELIMUMAB THERAPY IN LUPUS NEPHRITIS: A SINGLE-CENTRE OBSERVATIONAL STUDY
Marques Ortega, Francisco Javier; (...); Hernandez Jaras, Julio
Meeting Abstract. 2023
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Combined Liver-Kidney Transplantation in High Immunologic Risk Recipients: Kidney Graft Evolution.
Cholbi, Ester; (...); Hernandez, Julio
Article. 10.1016/j.transproceed.2022.10.007. 2022
Comparative Study of 2 Extended-Release Tacrolimus Formulations in Kidney Transplantation.
Cholbi Vives, Ester; (...); Hernandez Jaras, Julio
Article. 10.1016/j.transproceed.2022.10.001. 2022
Comprehensive Metabolomic Profiling in Adults with X-Linked Hypophosphatemia: A Case-Control Study
Lopez-Romero, Luis Carlos; (...); Hernandez-Jaras, Julio
Article. 10.3390/biomedicines13010022. 2025
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 2024
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
CHRONIC KIDNEY DISEASE IN NON-RENAL SOLID ORGAN TRANSPLANTATION: WHAT IS THE ROLE OF THE NEPHROLOGIST?
Viejo Boyano, Iris; (...); Hernandez Jaras, Julio
Meeting Abstract. 2023
Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
Abad, Maria Reyes; (...); Gil, Alicia
Article. 10.33393/grhta.2024.3041. 2024
Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis
Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther
Article. 10.1002/jvc2.275. 2024
DIFFERENTIAL LIPIDIC PROFILE WITH THE USE OF CITRATE OR ACETATE DIALYSATES
Broseta Monzo, Jose Jesus; (...); Hernandez Jaras, Julio
Meeting Abstract. 2023
Early Metabolomic Profiling as a Predictor of Renal Function Six Months After Kidney Transplantation
Viejo-Boyano, Iris; (...); Hernandez-Jaras, Julio
Article. 10.3390/biomedicines12112424. 2024
Enhancing critical care nephrology: analyzing continuous renal replacement therapy with a citrate-based anticoagulation focus
Viejo-Boyano, Iris; (...); Hernandez Jaras, Julio
Meeting Abstract. 10.1093/ndt/gfae069.1148. 2024
Fibrillary glomerulonephritis: more frequent than it seems? The diagnostical importance of immunohistochemistry.
Viejo-Boyano I; (...); Hernández-Jaras J
Letter. 10.1016/j.nefroe.2023.05.022. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Glomerulonefritis fibrilar: ¿Más frecuente de lo que parece? La importancia de la inmunohistoquímica en el diagnóstico
Viejo-Boyano, Iris; (...); Hernandez-Jaras, Julio
Editorial Material. 10.1016/j.nefro.2023.05.001. 2024
Gradient diffusion strips for detecting azole resistance in Aspergillus fumigatus sensu lato.
Serrano-Lobo J; (...); ASPEIN Study Group
Article. 10.1111/myc.13541. 2022
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Immunogenicity of COVID-19 vaccines in lung cancer patients.
Provencio M; (...); Calvo V
Article. 10.1016/j.lungcan.2023.107323. 2023
Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.
Pozo-Rosich P; (...); Irimia P
Article. 10.1186/s10194-024-01747-w. 2024
Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.
Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula
Article. 10.3390/antibiotics13080706. 2024
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
Metabolic Pathways Affected in Patients Undergoing Hemodialysis and Their Relationship with Inflammation.
Peris-Fernández M; (...); Hernández-Jaras J
Article. 10.3390/ijms25179364. 2024
Metabolomics of Plasma in XLH Patients with Arterial Hypertension: New Insights into the Underlying Mechanisms
Lopez-Romero, Luis Carlos; (...); Hernandez-Jaras, Julio
Article. 10.3390/ijms25063545. 2024
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Review. 10.3390/biology12091159. 2023
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 2024
Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.
Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis
Article. 10.3390/ijms26041760. 2025
Practical Requirements for the Development of an Advanced Cardiorenal Unit
Almenar-Bonet, Luis; (...); Sanchez-Perez, Pilar
Review. 10.1159/000536104. 2024
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
Role of the Nephrologist in Non-Kidney Solid Organ Transplant (NKSOT).
Viejo-Boyano, Iris; (...); Hernandez-Jaras, Julio
Article. 10.3390/healthcare11121760. 2023
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).
Badia, Xavier; (...); Valles, Joan-Antoni
Article. 10.1186/s13023-024-03324-5. 2024
Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.
Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis
Article. 10.1136/ejhpharm-2024-004184. 2024
Unraveling enteric peritonitis risk factors: the role of nutrition
Mompo-Ramos, Mar; (...); Hernandez Jaras, Julio
Meeting Abstract. 10.1093/ndt/gfae069.924. 2024
Uremic Toxins and Inflammation: Metabolic Pathways Affected in Non-Dialysis-Dependent Stage 5 Chronic Kidney Disease
Peris-Fernandez, Maria; (...); Hernandez-Jaras, Julio
Article. 10.3390/biomedicines12030607. 2024
Uremic toxins and inflammation: Metabolic pathways affected in stage 5 kidney disease
Peris-Fernandez, Maria; (...); Hernandez Jaras, Julio
Meeting Abstract. 10.1093/ndt/gfae069.483. 2024
VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA
Poveda, J. L.; (...); Lizan, L.
Meeting Abstract. 2023
X-Linked hypophosphatemia. Data from a Spanish adult population cohort.
Lopez-Romero, Luis Carlos; (...); Hernandez-Jaras, Julio
Article. 10.1007/s40620-024-01962-3. 2024