Surrogate Endpoints in IgA Nephropathy
IgA nephropathy, the most common glomerular disease worldwide, may progress to kidney failure over many years. There are no approved treatments and no accepted surrogate endpoints for registration of investigational products for this disease. The goals of this project are to evaluate and identify surrogate endpoint(s) for use in clinical trials in patients with different risks of progression to kidney failure. The workgroup, representing all KHI stakeholders, will critically analyze data from the literature, available patient registries and clinical trials and critically evaluate candidate surrogate endpoints according to the general criteria considered by the Food and Drug Administration.
Proteinuria Reduction as a Surrogate End Point in Trials of IgA Nephropathy