Clinical Trial Endpoints

Clinical Trial Endpoints for Dialysis Vascular Access

This project convened diverse stakeholders (health professionals, industry, dialysis organizations, and federal agencies) to clarify appropriate trial endpoints for vascular access trials best suited to inform clinical, regulatory, and coverage decisions, in those circumstances where clinical data is required to support the decisions. The workgroup developed parallel white papers on catheters, fistulas, and grafts endpoints. Learn more about this project here.

Clinical Trial End Points for Hemodialysis Vascular Access FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access Recommended Clinical Trial End Points for Dialysis Catheters Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access

Outcome Measures in Lupus Nephritis Trials

In partnership with the Lupus Nephritis Trial Network, a workgroup analyzed existing data to test for clear, valid endpoints for lupus nephritis trials. The workgroup contacted pharmaceutical companies that have completed trials in lupus nephritis to discuss the inclusion of their data in this project. Recognizing the value of including physicians treating these patients, the workgroup recruited global cohort sites to participate in the project.

Upon completion of the data analysis, the workgroup recommended a core set of outcome measures, biomarkers, surrogate markers, and clearly defined terms that should be incorporated into all future lupus nephritis trials. Developing these measures will make it much more feasible for companies to invest in the research necessary to improve treatments for patients with this serious disease.

Establishing Surrogate Kidney Endpoints for Lupus Nephritis Clinical Trials: Development and Validation of a Novel Approach to Predict Future Kidney Outcomes

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