Completed – Page 2 – Kidney Health Initiative (KHI)

End Stage Kidney Disease Data Standards

A Kidney Health Initiative working group developed data standards for ESKD that support consistency in research studies across settings and countries.

Drug Development in Children with Kidney Diseases

Drug and device developers face major obstacles in conducting trials to advance diagnosis and treatment of children with kidney diseases, also known as Chronic Kidney Disease (CKD). The rarity of pediatric patients with kidney diseases and their broad dispersion across the globe contributes to these obstacles.

Data Standards in Diabetic Kidney Disease

In coordination with the Clinical Data Interchange Standards Consortium (CDISC), Coalition for Accelerating Standards and Therapies (CFAST), FDA, and TransCelerate BioPharma, Inc., KHI assembled a working group that helped define appropriate standards in the therapeutic area of diabetic kidney disease.

Data Harmonization in Kidney Transplantation

There is currently a lack of consensus for not only clinical trial endpoints in transplant, but also for established standards for clinical research data collection, to support the acquisition, exchange, and comparisons of future trials.

Xenotransplantation: Knowledge and Perception Assessment

The advent of genome editing enabled xenotransplantation researchers to potentially overcome one of the greatest obstacles of xenotransplantation: immune rejection of xenogeneic organs in human recipients.

Including People with Kidney Diseases in COVID-19 Clinical Trials

In addition to threatening the lives of people with kidney diseases with risk of severe disease and infection, the COVID-19 pandemic put in jeopardy the advancement of innovative therapies for people with kidney diseases that have emerged over the past decade.

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.