{"id":70541,"date":"2026-04-28T13:45:09","date_gmt":"2026-04-28T17:45:09","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/?p=70541"},"modified":"2026-04-29T13:29:34","modified_gmt":"2026-04-29T17:29:34","slug":"jennifer-e-flythe-to-co-lead-17m-pcori-trial-to-slow-the-progression-of-kidney-disease","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/medicine\/news\/jennifer-e-flythe-to-co-lead-17m-pcori-trial-to-slow-the-progression-of-kidney-disease\/","title":{"rendered":"Jennifer E. Flythe To Co-Lead $17M Trial to Slow the Progression of Kidney Disease"},"content":{"rendered":"

A five-year, multisite clinical trial will compare two medication strategies for advanced chronic kidney disease, enrolling 1,350 participants nationwide.<\/em><\/p>\n

\n

Advanced chronic kidney disease (CKD) affects over 1 million people in the US. Individuals with advanced CKD have high risks of kidney failure requiring dialysis or transplantation, cardiovascular events, hospitalizations, and death, as well as a decline in quality of life. Renin-angiotensin system inhibitors (RASi) are the standard therapy for improving these outcomes in this population. In less advanced CKD, sodium-glucose cotransporter-2 inhibitors (SGLT2i), when added to RASi, reduce the risks of CKD progression and cardiovascular complications. Uncertainty remains about the effectiveness of starting SGLT2i in people with advanced CKD in real-world care environments. This evidence gap contributes to under-prescription of these therapies, particularly among individuals from traditionally disadvantaged populations.<\/p>\n

\"\"A new patient-centered comparative clinical effectiveness research (CER) project co-led by Jennifer E. Flythe, MD, MPH,<\/a> Professor of Medicine and Chief of the UNC Division of Nephrology and Hypertension, aims to evaluate whether adding an SGLT2i to background RASi therapy improves kidney and cardiovascular outcomes and preserves quality of life for people with advanced CKD. The findings will help clinicians weighing treatment options and health system leaders seeking to improve equitable access and uptake of these medications.<\/p>\n

The Helping Optimize Pharmacologic Effectiveness in Advanced CKD (HOPE-CKD) Trial will:<\/h5>\n

1) evaluate the comparative effectiveness of RASi plus SGLT2i vs. RASi alone as treatment options for reducing death, initiation of kidney replacement therapy (dialysis or kidney transplant), cardiovascular events, and hospitalizations, and preserving quality of life<\/p>\n

2) identify factors affecting the equitable prescription and uptake of these medications in clinical practice. Conducted in real-world care settings, the study will generate evidence on outcomes that matter to patients, helping them and their clinicians and health care teams make better-informed decisions.<\/p>\n

3) run as a Type 1 hybrid, pragmatic, randomize clinical trial at 10 PCORnet-enabled health systems, enrolling 1,350 total adults with CKD not yet treated with dialysis or kidney transplantation. Each patient with receive either RASi alone or RASi plus an SGLT2i. Prescription and management of medications after randomization will be handled by each participant\u2019s treating nephrologist as would occur in real-world care.<\/p>\n

The trial leverages the PCORnet (Patient-Center Outcomes Research Institute) infrastructure to support efficient cohort discovery, recruitment, pragmatic data collection, and follow-up. Patients, caregivers, doctors, pharmacists, health system leaders, insurers, and advocacy group representatives helped select the study outcomes, outcomes that they say matter most to people with advanced CKD. This stakeholder engagement and oversight will continue throughout the trial, operationalized via a Stakeholder Board, Workgroups, and representation on the Trial Steering Committee and Data Safety Monitoring Board.<\/p>\n

By embedding this pragmatic trial within PCORnet health systems with diverse populations and robust stakeholder involvement, HOPE-CKD will generate high-quality, patient-centered evidence on the effectiveness of adding SGLT2i to RASi therapy for people with advanced CKD and will provide actionable strategies to promote equitable adoption of the effective medication strategy.<\/p>\n

The study is funded through an award from the Patient-Centered Outcomes Research Institute (PCORI) to Baylor Scott & White Research Institute, which has been approved pending completion of PCORI\u2019s business and programmatic review and issuance of a formal award contract. PCORI<\/a> is a nonprofit organization with a mission to fund patient-centered CER designed to provide patients and those who care for them with evidence to make better-informed health care decisions.<\/p>\n","protected":false},"excerpt":{"rendered":"

A five-year, multisite clinical trial will compare two medication strategies for advanced chronic kidney disease, enrolling 1,350 participants nationwide. Advanced chronic kidney disease (CKD) affects over 1 million people in the US. Individuals with advanced CKD have high risks of kidney failure requiring dialysis or transplantation, cardiovascular events, hospitalizations, and death, as well as a … Read more<\/a><\/p>\n","protected":false},"author":112673,"featured_media":28664,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[101,2,644],"tags":[],"class_list":["post-70541","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nephrology","category-news","category-research-funding","odd"],"acf":[],"yoast_head":"\nJennifer E. 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