Kidney Health Initiative (KHI)

KHI Current Project

Identifying Surrogate Endpoints for Clinical Trials in IgA Nephropathy

Patient Care Issue:

IgA is an antibody––a protein made by the immune system to protect the body from foreign substances such as bacteria or viruses. IgA nephropathy is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues and can lead to end-stage kidney disease (ESKD) or the need for dialysis.

Challenge:

Clinical trial endpoints measure success or failure of therapies being tested. Unfortunately, no well-defined endpoints exist for IgA nephropathy. Without clear endpoints, researchers and industry face challenges developing new therapies for the disease. This is an important barrier to innovative drug development in this field.

KHI Solution:

A KHI workgroup has been assembled to discuss clinical trials in IgA nephropathy and to outline the challenges currently facing pharmaceutical companies. The first step will be to published a white paper on drug development in IgA nephropathy. If deemed necessary, a second step of data collection and analysis will be completed to confirm any recommendations. At the conclusion, the workgroup will recommend endpoints that should be incorporated into all future IgA nephropathy clinical 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.

Status:

The KHI workgroup has recently been confirmed and started regular meetings by phone.

Deliverable:

Publication.

Timeframe for Completion

Spring 2017.

Workgroup:
Chairs:

Patrick Nachman, MD
University of North Carolina Kidney Center

Aliza Thompson, MD
Division of Cardiovascular and Renal Products Center for Drug Evaluation and Research, FDA


Members:

Jonathan Barratt, PhD, FRCP
University of Leicester, United Kingdom

Kevin J. Carroll, PhD
KJC Statistics Limited

Daniel Cattran, MD
University of Toronto, Canada

Jürgen Floege, MD
University of Aachen, Germany

Barbara S. Gillespie, MD, MMS, FASN
Quintiles Global CRO

Annamaria T. Kausz, MD, MS
Allena Pharmaceuticals

Alex Mercer, PhD
Pharmalink AB

Heather Reich, MD, CM, PhD, FRCPC
University of Toronto, Canada

Brad H. Rovin, MD
The Ohio State University


KHI Board of Directors Liaison:

Ronald J. Falk, MD, FASN
University of North Carolina Chapel Hill

Additional Support Provided by:

Sonia Boyer, MD
University of North Carolina

Rupert Major, PhD
University of Leicester, United Kingdom

Judith Schimpf
University of Aachen, Germany


Conflict of Interest:

To view KHI's Conflict of Interest and Disclosure Policy, please click here.

To view the Workgroup's Disclosures, please click here.

If you have any questions, please do not hesitate to contact KHI at khi@asn-online.org.