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CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease

2018; Elsevier BV; Volume: 73; Issue: 2 Linguagem: Inglês

10.1053/j.ajkd.2018.07.020

1523-6838

Laura Mariani, Andrew S. Bomback, Pietro A. Canetta, Michael F. Flessner, Margaret E. Helmuth, Michelle Hladunewich, Jonathan Hogan, Krzysztof Kiryluk, Patrick H. Nachman, Cynthia C. Nast, Michelle N. Rheault, Dana V. Rizk, Howard Trachtman, Scott E. Wenderfer, Corinna Bowers, Peg Hill-Callahan, Maddalena Marasà, Caroline J. Poulton, Adelaide Revell, Suzanne Vento, Laura Barisoni, D C Cattran, Vivette D. D’Agati, J. Charles Jennette, Jon B. Klein, Louis‐Philippe Laurin, Katherine Twombley, Ronald J. Falk, Ali G. Gharavi, Brenda W. Gillespie, Debbie S. Gipson, Larry A. Greenbaum, Lawrence B. Holzman, Matthias Kretzler, Bruce Robinson, William E. Smoyer, Lisa M. Guay‐Woodford, Wooin Ahn, Gerald B. Appel, Revekka Babayev, Ibrahim Batal, Andrew S. Bomback, Eric J. Brown, Eric S. Campenot, Pietro A. Canetta, Lucrezia Carlassara, Brenda Chan, Debanjana Chatterjee, Vivette D. D’Agati, Elisa Delbarba, Samriti Dogra, Hilda Fernández, Bartosz Foroncewicz, Ali G. Gharavi, Gian Marco Ghiggeri, William H. Hines, S. Ali Husain, Namrata G. Jain, Pascale Khairallah, Byum Hee Kil, Krzysztof Kiryluk, Anushya Jeyabalan, Wai Lam Lau, Fangming Lin, Francesca Lugani, Maddalena Marasà, Glen S. Markowitz, Sumit Mohan, Xueru Mu, Krzysztof Mucha, Thomas L. Nickolas, Stacy Piva, Jai Radhakrishnan, Maya K. Rao, Renu Regunathan-Shenk, Simone Sanna‐Cherchi, Dominick Santoriello, Shayan Shirazian, Michael B. Stokes, Natalie Yu, Anthony M. Valeri, Ronald Zviti, Larry A. Greenbaum, William E. Smoyer, Amira Al‐Uzri, Josephine M. Ambruzs, Isa Ashoor, Diego Avilés, Rossana Baracco, John Barcia, Sharon M. Bartosh, Craig W. Belsha, Corinna Bowers, Michael Braun, Yi Cai, Vladimir Chernitskiy, Aftab S. Chishti, Donna Claes, Kira Clark, Carl H. Cramer, Keefe Davis, Amy Dutcher, Elif Erkan, Daniel I. Feig, Michael Freundlich, Joseph P. Gaut, Rasheed Gbadegesin, Melisha Hanna, Guillermo Hidalgo, David K. Hooper, Tracy E. Hunley, Amrish Jain, Mahmoud Kallash, Margo Kamel, Myda Khalid, Jon B. Klein, Theresa Kump, Jerome C. Lane, Helen Liapis, John D. Mahan, Nisha Mathews, Carla Nester, Cynthia G. Pan, Larry T. Patterson, Hiren P. Patel, Alice A. Raad, Adelaide Revell, Michelle N. Rheault, Cynthia Silva, Rajasree Sreedharan, Tarak Srivastava, Julia Steinke, Susan Sumner, Katherine Twombley, Scott E. Wenderfer, Tetyana L. Vasylyeva, Chia-shi Wang, Donald J. Weaver, Craig S. Wong, Hong Yin, Anand Achanti, Salem Almaani, Isabelle Ayoub, Milos N. Budisavljevic, Maggie D’Angelo, Vimal K. Derebail, Huma Fatima, Ronald J. Falk, Agnes B. Fogo, Keisha Gibson, Dorey A. Glenn, Susan L. Hogan, Koyal Jain, J. Charles Jennette, Bruce A. Julian, Jason M. Kidd, Louis‐Philippe Laurin, H. Davis Massey, Amy K. Mottl, Shannon L. Murphy, Tibor Nádasdy, Jan Novák, Samir M. Parikh, Caroline J. Poulton, Thomas Brian Powell, Bryce B. Reeve, Matthew B. Renfrow, Monica L. Reynolds, Dana V. Rizk, Brad H. Rovin, Virginie Royal, Manish K. Saha, Neil Sanghani, Sally Self, Sharon G. Adler, Nada Alachkar, Charles E. Alpers, Raed Bou Matar, Carmen Ávila-Casado, Serena M. Bagnasco, Emily Brede, Elizabeth Brown, Daniel C. Cattran, Michael Choi, Gabriel Contreras, Katherine M. Dell, Darren A. DeWalt, Michelle Denburg, Ram Dukkipati, Fernando C. Fervenza, Alessia Fornoni, Crystal A. Gadegbeku, Patrick Gipson, Anny Gonzalez-Zea, Leah Hasely, Elizabeth Hendren, Sangeeta Hingorani, Michelle Hladunewich, Jonathan Hogan, Lawrence B. Holzman, Jean Hou, J. Ashley Jefferson, Kenar D. Jhaveri, Duncan B. Johnstone, Frederick J. Kaskel, Amy Kogan, Jeffrey B. Kopp, Richard A. Lafayette, Kevin V. Lemley, Laura Málaga-Diéguez, Kevin Meyers, Alicia M. Neu, Michelle M. O’Shaughnessy, John F. O’Toole, Andrea L. Oliverio, Matthew Palmer, Rulan S. Parekh, Renée Pitter, Heather N. Reich, Kimberly Reidy, Helbert Rondon‐Berrios, Kamalanathan K. Sambandam, Matthew G. Sampson, John R. Sedor, David T. Selewski, Christine B. Sethna, Jeffrey R. Schelling, C. John Sperati, Agnieszka Swiatecka‐Urban, Howard Trachtman, Katherine R. Tuttle, Meryl Waldman, Joseph Weisstuch, Roger C. Wiggins, David Williams, Cheryl A. Winkler, Suzanne Vento, Eric W. Young, Olga Zhdanova, Laura Barisoni, Charlotte A. Beil, Richard Eikstadt, Brenda W. Gillespie, Debbie S. Gipson, John Graff, Stephen M. Hewitt, Peg Hill-Callahan, Margaret E. Helmuth, Emily Herreshoff, Matthias Kretzler, Chrysta Lienczewski, Sarah Mansfield, Laura Mariani, Keith McCullough, Nicholas Moore, Cynthia C. Nast, Bruce Robinson, Melissa Sexton, Jonathan P. Troost, Matthew Wladkowski, Jarcy Zee, Dawn Zinsser, Lisa M. Guay‐Woodford,

Ovarian cancer diagnosis and treatment

Glomerular diseases, including minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, and immunoglobulin A (IgA) nephropathy, share clinical presentations, yet result from multiple biological mechanisms. Challenges to identifying underlying mechanisms, biomarkers, and new therapies include the rarity of each diagnosis and slow progression, often requiring decades to measure the effectiveness of interventions to prevent end-stage kidney disease (ESKD) or death.Multicenter prospective cohort study.Cure Glomerulonephropathy (CureGN) will enroll 2,400 children and adults with minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, or IgA nephropathy (including IgA vasculitis) and a first diagnostic kidney biopsy within 5 years. Patients with ESKD and those with secondary causes of glomerular disease are excluded.Clinical data, including medical history, medications, family history, and patient-reported outcomes, are obtained, along with a digital archive of kidney biopsy images and blood and urine specimens at study visits aligned with clinical care 1 to 4 times per year.Patients are followed up for changes in estimated glomerular filtration rate, disease activity, ESKD, and death and for nonrenal complications of disease and treatment, including infection, malignancy, cardiovascular, and thromboembolic events.The study design supports multiple longitudinal analyses leveraging the diverse data domains of CureGN and its ancillary program. At 2,400 patients and an average of 2 years' initial follow-up, CureGN has 80% power to detect an HR of 1.4 to 1.9 for proteinuria remission and a mean difference of 2.1 to 3.0mL/min/1.73m2 in estimated glomerular filtration rate per year.Current follow-up can only detect large differences in ESKD and death outcomes.Study infrastructure will support a broad range of scientific approaches to identify mechanistically distinct subgroups, identify accurate biomarkers of disease activity and progression, delineate disease-specific treatment targets, and inform future therapeutic trials. CureGN is expected to be among the largest prospective studies of children and adults with glomerular disease, with a broad goal to lessen disease burden and improve outcomes.