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1. The Role of Rituximab in Primary Focal Segmental Glomerular Sclerosis of the Adult

Author

Martina Tedesco, Federica Mescia, Isabella Pisani, Marco Allinovi, Giovanni Casazza, Lucia Del Vecchio, Marisa Santostefano, Luigi Cirillo, Francesca Ferrario, Ciro Esposito, Pasquale Esposito, Domenico Santoro, Roberta Lazzarin, Giovanni Maria Rossi, Enrico Fiaccadori, Angelo Ferrantelli, Renato Alberto Sinico, Mario Cozzolino, Maurizio Gallieni, Lino Cirami, Francesco Scolari, Augusto Vaglio, Federico Alberici, Stefania Affatato, Leonardo Caroti, Elena Mancini, Luca Semeraro, Rossella Siligato, Matthias Arnaldo Cassia, Pietro Napodano, Marta Calatroni, Cosimo Distratis, Andrea Campo, Tedesco, M, Mescia, F, Pisani, I, Allinovi, M, Casazza, G, Del Vecchio, L, Santostefano, M, Cirillo, L, Ferrario, F, Esposito, C, Esposito, P, Santoro, D, Lazzarin, R, Rossi, G, Fiaccadori, E, Ferrantelli, A, Sinico, R, Cozzolino, M, Gallieni, M, Cirami, L, Scolari, F, Vaglio, A, Alberici, F, Affatato, S, Caroti, L, Mancini, E, Semeraro, L, Siligato, R, Cassia, M, Napodano, P, Calatroni, M, Distratis, C, and Campo, A

Subjects
rituximab, Nephrology, focal segmental glomerulosclerosi
Abstract

Introduction: Primary focal segmental glomerular sclerosis (FSGS) is a rare, likely immune-mediated disease. Rituximab (RTX) may play a role in management, although data in adults are scanty. Methods: We collected cases of RTX-treated primary FSGS within the Italian Society of Nephrology Immunopathology Working Group and explored response rate (24-hour proteinuria

Published
2022
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2. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults

Author

Thomas Barbour, Marie Scully, Gema Ariceta, Spero Cataland, Katherine Garlo, Nils Heyne, Yosu Luque, Jan Menne, Yoshitaka Miyakawa, Sung-Soo Yoon, David Kavanagh, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Eric Rondeau, Hermann Haller, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Barbour T., Scully M., Ariceta G., Cataland S., Garlo K., Heyne N., Luque Y., Menne J., Miyakawa Y., Yoon S.-S., Kavanagh D., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Campistol J.M., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Le Quintrec M., Jeantet G., Fumie I., Rondeau E., Haller H., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., Wong E.K.S., Institut Català de la Salut, [Barbour T] Kidney Care, The Royal Melbourne Hospital, Melbourne, Australia. [Scully M] Department of Haematology, University College London Hospitals, London, UK. [Ariceta G] Servei de Nefrologia Pediàtrica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Cataland S] Division of Hematology, The Ohio State University Medical Center, Columbus, Ohio, USA. [Garlo K] Clinical Development, Alexion Pharmaceuticals, Inc., Boston, Massachusetts, USA. [Heyne N] Section of Nephrology and Hypertension, Tübingen University Hospital, Tübingen, Germany, Vall d'Hebron Barcelona Hospital Campus, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, The Royal Melbourne Hospital, University College London Hospitals (UCLH), Vall d'Hebron University Hospital [Barcelona], Ohio State University [Columbus] (OSU), Universitätsklinikum Tübingen - University Hospital of Tübingen, Eberhard Karls Universität Tübingen = Eberhard Karls University of Tuebingen, Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), Seoul National University Hospital, and Newcastle University [Newcastle]

Subjects
medicine.medical_specialty, Thrombotic microangiopathy, [SDV]Life Sciences [q-bio], Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia::Anemia, Hemolytic::Hemolytic-Uremic Syndrome::Hemic and Lymphatic Diseases::Hematologic Diseases::Atypical Hemolytic Uremic Syndrome [DISEASES], 030232 urology & nephrology, Renal function, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], 030204 cardiovascular system & hematology, Other subheadings::Other subheadings::/drug therapy [Other subheadings], 03 medical and health sciences, 0302 clinical medicine, afecciones patológicas, signos y síntomas::procesos patológicos::atributos de la enfermedad::enfermedades raras [ENFERMEDADES], Clinical Research, Internal medicine, Atypical hemolytic uremic syndrome, Medicine, complement, Adverse effect, Complement component 5, business.industry, Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Rare Diseases [DISEASES], atypical hemolytic uremic syndrome, Acute kidney injury, diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], medicine.disease, Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], ravulizumab, Diseases of the genitourinary system. Urology, 3. Good health, enfermedades hematológicas y linfáticas::enfermedades hematológicas::anemia::anemia hemolítica::síndrome hemolítico-urémico::enfermedades hematológicas y linfáticas::enfermedades hematológicas::síndrome hemolítico urémico atípico [ENFERMEDADES], kidney failure, thrombotic microangiopathy, Clinical trial, Nephrology, Avaluació de resultats (Assistència sanitària), hemolytic uremic syndrome, RC870-923, Síndrome hemolíticourèmica - Tractament, Malalties rares, business, Kidney disease
Abstract

Hemolytic uremic syndrome; Kidney failure; Ravulizumab Síndrome hemolítico urémico; Insuficiencia renal; Ravulizumab Síndrome hemolític urèmic; Insuficiència renal; Ravulizumab Introduction Atypical hemolytic uremic syndrome (aHUS) is a rare, complex, multisystem disease of dysregulated complement activity, characterized by progressive thrombotic microangiopathy (TMA), acute kidney injury, and multiorgan dysfunction, which often progresses to chronic kidney disease. Results from the prospective clinical trial of ravulizumab (NCT02949128) reveal rapid resolution of TMA in patients with aHUS, with sustained efficacy and safety in a 26-week initial evaluation period. Methods The aim of this analysis was to characterize the long-term efficacy and the safety profile of ravulizumab in adults with aHUS who had completed the initial evaluation period of the trial. Complete TMA response, hematologic and kidney functions, and safety were evaluated for all patients available for follow-up in the extension period (median follow-up: 76.7 weeks; range: 0.6–118.3). This trial included a total of 58 patients, 49 of whom entered the extension period. Results A total of 4 additional patients achieved complete TMA response during the follow-up period. Normalization of platelet count, serum lactate dehydrogenase (LDH), and hemoglobin observed in the 26-week initial evaluation period was sustained until the last available follow-up, as were the improvements in the estimated glomerular filtration rate (eGFR) and patient quality of life. All efficacy endpoints were correlated with the sustained inhibition of complement C5. Most adverse events (AEs) occurred early during the initial evaluation period and decreased substantially during the extension period. No patient developed a meningococcal infection or died during the extension period. Conclusion This analysis reveals that ravulizumab administered every 8 weeks is efficacious with an acceptable safety profile for the long-term treatment of adults with aHUS and provides additional clinical benefit beyond 6 months of treatment.

Published
2021
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3. Corrigendum to 'Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, Miyakawa Y, Ortiz S, Swenson E, Vallee M, Yoon S-S, Kavanagh D and Haller H; on behalf of the 311 Study Group. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment.' Kidney Int. 2020;97:1287–1296

Author

Eric Rondeau, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, Stephan Ortiz, Eugene Swenson, Marc Vallee, Sung-Soo Yoon, David Kavanagh, Hermann Haller, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Miquel Blasco, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Giorgia Comai, Maria Cappuccilli, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Yosu Luque, Jan Menne, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Elena Gutierréz, Paola Rodriguez, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Rondeau E., Scully M., Ariceta G., Barbour T., Cataland S., Heyne N., Miyakawa Y., Ortiz S., Swenson E., Vallee M., Yoon S.-S., Kavanagh D., Haller H., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Campistol J.M., Blasco M., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Comai G., Cappuccilli M., Le Quintrec M., Jeantet G., Fumie I., Luque Y., Menne J., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Gutierrez E., Rodriguez P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., and Wong E.K.S.

Subjects
Kidney, medicine.medical_specialty, Adult patients, business.industry, INT, medicine.disease, Gastroenterology, Complement inhibitor, medicine.anatomical_structure, Long acting, Nephrology, Internal medicine, Atypical hemolytic uremic syndrome, Medicine, Ravulizumab, Thrombotic microangiopathy, Pregnancy microangiopathies, Atypical hemolytic uremic syndrome, business
Abstract

The authors regret that 2 investigators were not included in the 311 Study Group. Members of the 311 Study Group are listed in the Appendix. The authors would like to apologize for any inconvenience caused.

Published
2021
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4. Erratum to 'Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, Miyakawa Y, Ortiz S, Swenson E, Vallee M, Yoon S-S, Kavanagh D, Haller H; on behalf of the 311 Study Group. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment' Kidney Int. 2020;97:1287–1296

Author

Eric Rondeau, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, Stephan Ortiz, Eugene Swenson, Marc Vallee, Sung-Soo Yoon, David Kavanagh, Hermann Haller, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Giorgia Comai, Maria Cappuccilli, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Yosu Luque, Jan Menne, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Elena Gutierréz, Paola Rodriguez, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Rondeau E., Scully M., Ariceta G., Barbour T., Cataland S., Heyne N., Miyakawa Y., Ortiz S., Swenson E., Vallee M., Yoon S.-S., Kavanagh D., Haller H., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Comai G., Cappuccilli M., Le Quintrec M., Jeantet G., Fumie I., Luque Y., Menne J., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Gutierrez E., Rodriguez P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., and Wong E.K.S.

Subjects
N.A, Nephrology
Abstract

The publisher regrets that the members of the 311 Study Group were not included as collaborative authors. Members of the 311 Study Group are listed in the Appendix. The publisher would like to apologize for any inconvenience caused.

Published
2020
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5. Parapelvic cysts, a distinguishing feature of renal Fabry Disease

Author

Massimo Sabbatini, Dario Bruzzese, Daniela Concolino, Sirio Cocozza, Carmela Zizzo, Leonardo Caroti, Massimiliano Veroux, Raffaele Manna, Michele Santangelo, Massimo Imbriaco, Luigi Petruzzelli Annicchiarico, Angela Maria Pellegrino, Yuri Battaglia, Antonio Pisani, Sandro Feriozzi, Enrico Tedeschi, Dario De Rosa, Simona Sestito, Federico Pieruzzi, Eleonora Riccio, Renzo Mignani, Pisani, Antonio, Annicchiarico, Luigi Petruzzelli, Pellegrino, ANGELA MARIA, Bruzzese, Dario, Feriozzi, Sandro, Imbriaco, Massimo, Tedeschi, Enrico, Cocozza, Sirio, Rosa, Dario De, Mignani, Renzo, Veroux, Massimiliano, Battaglia, Yuri, Concolino, Daniela, Sestito, Simona, Pieruzzi, Federico, Caroti, Leonardo, Manna, Raffaele, Zizzo, Carmela, Santangelo, Michele, Sabbatini, Massimo, Riccio, Eleonora, Pisani, A, Petruzzelli Annicchiarico, L, Pellegrino, A, Bruzzese, D, Feriozzi, S, Imbriaco, M, Tedeschi, E, Cocozza, S, De Rosa, D, Mignani, R, Veroux, M, Battaglia, Y, Concolino, D, Sestito, S, Pieruzzi, F, Caroti, L, Manna, R, Zizzo, C, Santangelo, M, Sabbatini, M, and Riccio, E

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Pathology, biomarkers, chronic renal failure, Fabry disease, parapelvic cyst, ultrasonography, Nephrology, Transplantation, 030232 urology & nephrology, Disease, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Prevalence, Medicine, Humans, Family history, Retrospective Studies, Ultrasonography, business.industry, Settore MED/09 - MEDICINA INTERNA, Ultrasound, Renal ultrasound, biomarkers, chronic renal failure, Fabry disease, parapelvic cyst, ultrasonography, Enzyme replacement therapy, Kidney Diseases, Cystic, Middle Aged, medicine.disease, Control subjects, Prognosis, 030104 developmental biology, Cross-Sectional Studies, Italy, alpha-Galactosidase, Cohort, biomarker, Fabry Disease, Female, business
Abstract

Background Fabry's disease (FD) is a rare, multi-organ lysosomal disease, caused by the deficiency of the enzyme α-galactosidase A, and is difficult to diagnose. Although parapelvic cysts (PC) were previously associated with FD, their prevalence and significance are unclear. Methods The present study aimed to: (i) evaluate, by renal ultrasound, the real prevalence of PC and of their determinants in a multicentre, nationwide cohort of FD patients (n = 173, Study 1) and (ii) ascertain whether a greater accuracy of PC detection improved their identification, in FD patients from a single centre (n = 67, Study 2). In both studies, for each FD patient, an age- and renal function-matched subject was selected for comparison (1:1). Results In Study 1, PC were detected in 28.9% of FD subjects and in only 1.1% of control subjects (P

Published
2018

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