GS-US-223-1017 - Selonsertib in Subjects with Moderate to Advanced DKD
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects with Moderate to Advanced Diabetic Kidney Disease.
IRAS ID
264338
Contact name
Christian Delles
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2018-003951-39
Duration of Study in the UK
4 years, 8 months, 0 days
Research summary
This clinical study is trying to see if the investigational product, Selonsertib, can slow down the decline in kidney function, reduce the risk of kidney failure, or reduce the risk of death due to kidney disease in patients suffering from diabetic kidney disease (DKD).
Diabetes mellitus is the leading cause of chronic kidney disease (CKD) in the developed world, accounting for half of all incident cases of kidney failure. Approximately 13 million people in the United States and European Union have CKD along with associated Type 2 Diabetes (T2DM). Approximately 10 million of these patients have CKD Stage 2-4 and the prevalence continues to increase in step with the increasing prevalence of T2DM and metabolic syndrome. Current standard of care therapies do not address the underlying pathological processes of chronic inflammation and oxidative stress that persist and drive disease progression through fibrosis. The continual decline in kidney function that occurs in many patients with DKD despite treatment with these approved therapies highlights the large unmet medical need.
The study will involve approximately 3300 patients from approximately 750 research sites globally. Within the UK, the study will be conducted within primary and secondary care facilities.
Patients aged between 18 - 80 years old with a diagnosis of Type 2 Diabetes Mellitus will be invited to take part.
This is an event-driven study and the estimated treatment duration is 21 months (1 month during the run-in period and an estimated treatment duration of 20 months post-randomisation).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0349
Date of REC Opinion
9 Dec 2019
REC opinion
Favourable Opinion