Kidney Health Initiative (KHI)

KHI Pilot Projects 2013

Outcome Measures in Lupus Nephritis Trials

Patient Care Issue:

Approximately 1.5 million Americans have systemic lupus erythematosus, and up to 60% of those patients may develop lupus nephritis, an inflammation of the kidney that can lead to chronic kidney disease (CKD) or end-stage renal disease (ESRD).

Challenge:

Clinical trial endpoints measure success or failure of therapies being tested. Unfortunately, no well-defined endpoints exist for lupus nephritis. 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 (in partnership with the Lupus Nephritis Trial Network) is analyzing 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 will recommend 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.

Status:

The KHI workgroup (in partnership with LNTN) recruited more than 10 global cohort sites to participate in the project, aggregated a data set of over 800 patients, and has completed their initial analysis. The workgroup is currently drafting their manuscript for publication.

Deliverable:

Publication

Timeframe for Completion:

November 2016.

KHI Workgroup:
Chair:
  • Brad Rovin, MD, FACP, FASN
    The Ohio State University
Members:
  • Patrick Archdeacon, MD
    Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA (KHI Co-Chair)
  • Maria Dall'Era, MD
    University of California, San Francisco
  • Kenneth Kalunian, MD
    University of California, San Diego
  • Larissa Lapteva, MD, MHS
    Center for Drug Evaluation and Research (CDER), FDA
  • Meggan Mackay, MD, MS
    Feinstein Institute for Medical Research, North Shore-Long Island Jewish Health System Foundation
  • Prabir Roy-Chaudhury, MD, PhD, FASN
    University of Arizona (KHI Co-Chair)
  • Laura Straub
    Immune Tolerance Network
  • Sarah Yim, MD
    Center for Drug Evaluation and Research (CDER), FDA

Additional support provided by:
  • Amrutha Baskaran, MD, MSCR
    Post-Doctoral Scholar, University of California, San Diego
  • Martin L. Lesser, PhD, EMT-CC
    Director and Investigator, Biostatistics Unit, Feinstein Institute for Medical Research
  • Joanna Fishbein, PhD
    Biostatistician Feinstein Institute for Medical Research

Conflict of Interest:

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