Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design.

ABSTRACT:

Background

The lack of adequate randomized clinical trials (RCT) has hindered identification of new therapies that are safe and effective for patients with primary focal segmental glomerulosclerosis (FSGS), especially in patients who fail to respond to corticosteroids and immunosuppressive therapies. Recent basic science advances have led to development of alternative treatments that specifically target aberrant pathways of fibrosis which are relevant to disease progression in FSGS. There is a need for a flexible Phase II study design which will test such novel antifibrotic strategies in order to identify agents suitable for phase III testing.

Methods/design

The Novel Therapies for Resistant Focal Segmental Glomerulosclerosis (FONT) project is a multicenter Phase I/II RCT de

SUBMITTER: Trachtman H 

PROVIDER: S-EPMC3045306 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature