NephCure Accelerating Cures Institute: A Multidisciplinary Consortium to Improve Care for Nephrotic Syndrome

Debbie S Gipson; David T Selewski; Susan F Massengill; Mary Margaret Modes; Hailey Desmond; Lauren Lee; Elaine Kamil; Matthew R Elliott; Sharon G Adler; Gia Oh; Richard A Lafayette; Patrick E Gipson; Aditi Sinha; Arvind Bagga; Anne Pesenson; Cheryl Courtlandt; Cathie Spino; Richard Eikstadt; Renée Pitter; Samara Attalla; Anne Waldo; Richard Winneker; Noelle E Carlozzi; Jonathan P Troost; Irving Smokler; Mark Stone

doi:10.1016/j.ekir.2017.11.016

NephCure Accelerating Cures Institute: A Multidisciplinary Consortium to Improve Care for Nephrotic Syndrome

Kidney Int Rep. 2017 Nov 28;3(2):439-446. doi: 10.1016/j.ekir.2017.11.016. eCollection 2018 Mar.

Authors

Debbie S Gipson¹, David T Selewski¹, Susan F Massengill², Mary Margaret Modes³, Hailey Desmond¹, Lauren Lee⁴, Elaine Kamil⁵, Matthew R Elliott⁶, Sharon G Adler⁷, Gia Oh⁸, Richard A Lafayette⁹, Patrick E Gipson¹, Aditi Sinha¹⁰, Arvind Bagga¹⁰, Anne Pesenson¹¹, Cheryl Courtlandt², Cathie Spino¹², Richard Eikstadt¹, Renée Pitter¹, Samara Attalla¹, Anne Waldo¹, Richard Winneker⁴, Noelle E Carlozzi¹³, Jonathan P Troost¹, Irving Smokler⁴, Mark Stone⁴

Affiliations

¹ Division of Nephrology, Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, Michigan, USA.
² Division of Pediatric Nephrology, Levine Children's Hospital, Charlotte, North Carolina, USA.
³ Livonia, Michigan, USA.
⁴ NephCure Kidney International, King of Prussia, Pennsylvania, USA.
⁵ Division of Pediatric Nephrology, Department of Pediatrics, Cedars-Sinai Medical Center, David Geffen School of Medicine at The University of California, Los Angeles, Los Angeles, California, USA.
⁶ Metrolina Nephrology Associates, Charlotte, North Carolina, USA.
⁷ Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, California, USA.
⁸ Division of Nephrology, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.
⁹ Division of Nephrology and Hypertension, Stanford University, Stanford, California, USA.
¹⁰ Division of Nephrology, Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.
¹¹ The Polyclinic, Seattle, Washington, USA.
¹² Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.
¹³ Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, Michigan, USA.

Abstract

Introduction: NephCure Accelerating Cures Institute (NACI) is a collaborative organization sponsored by NephCure Kidney International and the University of Michigan. The Institute is composed of 7 cores designed to improve treatment options and outcomes for patients with glomerular disease: Clinical Trials Network, Data Warehouse, Patient-Reported Outcomes (PRO) and Endpoints Consortium, Clinical Trials Consulting Team, Quality Initiatives, Education and Engagement, and Data Coordinating Center.

Methods: The Trials Network includes 22 community- and hospital-based nephrology practices, 14 of which are trial-only sites. Eight sites participate in the NACI Registry, and as of October 2017, 1054 patients are enrolled with diagnoses including but not limited to focal segmental glomerulosclerosis, minimal change disease, membranous nephropathy, IgA nephropathy, and childhood-onset nephrotic syndrome. By using electronic health record data extraction, robust and efficient clinical data are captured while minimizing the burden to site-based network staff.

Results: The Data Warehouse includes her-extracted data from registry patients, PRO development data, and data from completed observational studies and clinical trials. The Clinical Trial Consulting Team provides support for trial design in rare diseases leveraging these data. The PRO and Endpoints Consortium develops shorter-term endpoints while capturing the patient-reported significance of interventions under study. The Quality Initiatives and Education/Engagement cores elevate the level of care for patients. The Data Coordinating Center manages the analysis and operations of the Institute.

Conclusion: By engaging with patients, academia, industry, and patient advocate community representatives, including our Patient Advisory Board, NACI strives for better outcomes and treatments using evidence-based support for clinical trial design.

Keywords: clinical trials; electronic health record; glomerular disease; nephrotic syndrome; patient advisory; patient-reported outcomes.