NKF, FDA Host Conference to Assess Proteinuria as a Surrogate Outcome in Chronic Kidney Disease

On May 1-2, 2008, a unique scientific workshop was co-sponsored by the National Kidney Foundation (NKF) and the U.S. Food and Drug Administration (FDA), which brought together over 100 physicians to discuss proteinuria as a surrogate outcome in Chronic Kidney Disease (CKD). Conference participants shared data from numerous trials on proteinuria reduction and addressed issues such as the progression of kidney disease, laboratory measurement of proteinuria, clinical trial design and novel markers related to CKD.

While more data is needed, the conference was instrumental in bringing together those groups responsible for designing and conducting clinical trials: the FDA, nephrology experts, and industry. The next step will be a joint NKF-FDA publication summarizing the main conclusions from the conference. Other follow up activities will include efforts to further analyze existing data to evaluate the criteria for surrogacy, and to develop new disease models and trial designs.

Click here to see the agenda for the conference

Click here to see the roster of participants at the conference

To review the slide presentations from the conference click on the titles below, or
Click here to download all of the presentations at once

Session 1 - General

Proteinuria in CKD
Presenter: Andrew Levey and Daniel Cattran

Prevalence of albuminuria, and its relationship to decreased GFR and outcomes
Presenter: Josef Coresh

Mechanism of interventions to reduce proteinuria
Markers of kidney damage other than proteinuria/Proteomics
Presenter: Jeffrey Kopp

Measurement issues / Assay analytic issues
Presenter: Greg Miller

FDA perspective on surrogates/ critical path and
The current status of proteinuria as a surrogate marker in CKD
Presenter: Aliza Thompson

Assessing surrogacy in CKD
Presenter: Thomas Greene

Session 2 - Early Diabetes (microalbuminuria)

Summary of NKF-KDOQI guideline on Diabetes and CKD
with regards to proteinuria as an outcome
Presenter: Katherine Tuttle

Observational Studies
    Type I Diabetes
    Presenter: Bruce Perkins

     Type II Diabetes in American Indians
     Presenter: Robert Nelson

Clinical trials of CKD development, progression and remission:
    DCCT
    Presenter: Mark Molitch

    UKPDS
    Presenter: Rudy Bilous

    Micro-HOPE
    Presenter: Johannes Mann

    IRMA
    Presenter: Edmund Lewis

    RASS
    Presenter: Michael Mauer

Session 3 - Nephrotic Syndrome

Clinical trials of Nephrotic syndrome remission
    FSGS
    Presenter: Aaron Friedman

    Lupus nephritis
    Presenter: James Balow

    Idiopathic glomerular diseases in adults (membranous)
    Presenter: Daniel Cattran

Session 4 - CKD Progression

Clinical Trials (mostly but not all ACEI/ARB)
    AASK
    Presenter: Thomas Greene

    REIN and REIN 2
    Presenter: Giuseppe Remuzzi

    AIRPD meta-analysis
    Presenter: Tazeen Jafar

    RENAAL
    Presenter: Dick de Zeeuw

    IDNT
    Presenter: Edmund Lewis

Session 5 - CKD Progression (continued)

Clinical Trials (other than ACEI/ARB)
    MDRD (diet)
    Presenter: Thomas Greene

    lgA Trials
    Presenter: Ronald Hogg

    Sulodexide trials
    Presenter: Julia Lewis

    CKD-EPI meta-analysis
    Presenter: Lesley Stevens

Possible Conclusions from Conference
Presenter: Andrew Levey

The National Kidney Foundation gratefully acknowledges support from:

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