Completed – Kidney Health Initiative (KHI)

Developing a Roadmap to Accelerate the Expansion of AKI Biomarkers for Drug Development

Developing a Roadmap to Accelerate the Expansion of AKI Biomarkers for Drug Development Projects Portfolio: Drugs Barrier Type: Clinical Trial Endpoints Biomarkers—objective, measurable characteristics of biological processes—are critical to assess

Surrogate Endpoints in FSGS

Despite being associated with a relatively rapid decline in kidney function, there are no approved drugs and no accepted endpoints for registration of investigational products for FSGS.

Patient-Reported Outcome Measures for Novel Renal Devices

Attention to the innovation deficit in treatments for kidney failure is increasing. As development of next generate kidney replacement therapy begins to accelerate, the perspectives of people with kidney failure must not be overlooked.

Patient Reported Outcomes for Muscle Cramping

Muscle cramping is an especially bothersome symptom in patients receiving dialysis, regardless of modality.

Patient Advisory Boards

To further patient input in KHI, the Patient and Family Partnership Council (PFPC) partners with KHI Board of Directors (BOD) to advise and make recommendations on KHI member efforts so that the patient’s voice, experience, and involvement is meaningful and effective in biomedical research and product development.

Involving Kidney Patients in Cardiovascular Trials

Kidney disease is highly prevalent among patients with cardiovascular disease and is associated with worse cardiovascular outcomes.

Incorporating Patient Preferences in the Development of Novel Kidney Replacement Therapy

Accelerated innovation in the kidney community highlights the need for integrating the patient perspective at every step of the product lifecycle.

Endpoints for Hyperoxaluria Clinical Trials

Primary hyperoxaluria and enteric hyperoxaluria are rare disorders that cause frequent kidney stones, nephrocalcinosis, and kidney failure.

Endpoints for C3 Glomerulopathy (C3G)

C3 glomerulopathy (C3G) is a form of primary kidney disease characterized by the deposition of complement C3 fragments in glomeruli (1). C3G is a rare disease, with an estimated incidence of less than 1:1,000,000.

Patient Reported Outcomes for Dialysis Vascular Access

Vascular access affects the key outcomes for the more than 700,000 people on dialysis with kidney failure in the US. Access-related clinical events, such as infection and thrombosis, impact clinical outcomes and costs, and differ between access types.