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Clinical Trials to Advance Therapies for Nephropathy and Cardiovascular Disease in Type 1 Diabetes

Deadlines are 5:00 PM (Eastern). No extensions will be granted.


Milestone Date Status
Letter of Intent Required Nov 08, 2021 Passed
Application Jan 05, 2022 Next
Award Notification May 31, 2022
Earliest Start Aug 31, 2022

Background & Purpose

Please click on the “RFA Announcement” link for complete information.

PURPOSE

JDRF is committed to the development of therapies to improve clinical outcomes in people with type 1 diabetes (T1D). Despite advanced technologies to maintain glucose control, long-term complications such as diabetic nephropathy (DN) and cardiovascular disease (CVD) are still the primary cause of morbidity and mortality in people with T1D. There is currently a lack of targeted therapies for DN or CVD approved for use by people with T1D, in part because people with T1D are seldom included in drug trials for these diabetic complications. To fill this gap, JDRF invites applications for clinical trials to advance therapies to improve DN and/or CVD outcomes in T1D.

BACKGROUND

DN and CVD are common and clinically significant long-term complications of T1D. It has been estimated that at least half of people with T1D will be affected by DN, and CVD is the leading cause of mortality in adults with T1D. The two complications are closely linked, with DN acting as a major risk factor for negative CVD outcomes.

Despite the high prevalence and clinical impact of DN and CVD in T1D, there is a lack of effective treatment options approved for use in people with T1D for either condition. People with T1D have access to therapies to improve cardiorenal risk factors such as blood glucose, blood pressure, and lipids, but there remains a critical need for therapies that directly improve kidney and cardiovascular health in this population. The state of DN and CVD care for people with T1D stands in contrast to that of people with type 2 diabetes (T2D), who have available a number of drugs (e.g. SGLT inhibitors, GLP-1 receptor agonists, MRA/finerenone) with regulatory approvals for renal and/or cardiovascular health benefits. While these new drug classes are transforming cardiorenal care for people with T2D, and in some cases people without diabetes, people with T1D were excluded from the relevant clinical trials and today are excluded from these drugs’ labels. There is reason to be optimistic that these drug classes will improve cardiorenal health in people with T1D as in T2D, but trials collecting cardiovascular and renal clinical outcomes in people with T1D have not been done. Other drugs approved or in development for CVD and various kidney diseases may also represent promising candidates for people with T1D.

This RFA is intended to solicit proposals to advance drugs—novel or repositioned, in clinical development or already approved for an indication— for DN and/or CVD in T1D by executing clinical trials to assess efficacy and safety of these agents in this understudied population.