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RENAL ENDPOINTS IN CKD, HEART FAILURE AND DIABETES TRIALS. American Society of Nephrology (ASN) - Kidney Health Initiative (KHI) – CVCT Joint session

Chairpersons: Prabir Roy-Chaudhury (Tucson, USA); Patrick Rossignol (Nancy, FRA)
2.00 pm – 3.30 pm / 4.00 - 7.30 pm
 Cardiovascular death is either the leading or one of the main causes of death in
patients with chronic kidney disease (CKD).
 CKD is one of the main features associated with poor outcomes in cardiovascular
disease patients, especially those with heart failure and/or diabetes.
 The most suitable choice of components of the composite endpoint for a
cardiovascular outcome trial conducted specifically in the CKD population is
obviously key for success and depends on the specific therapy being tested.
 Renal endpoints are pathophysiologically relevant in a CKD population even if the
primary intervention target is cardiovascular disease, and a composite endpoint
reflecting both cardiovascular and renal outcomes may be desirable, especially if
the intervention is expected to affect both systems.
 However, a challenging problem is which endpoints to combine and how to
interpret the results of the composite endpoint.
 Moreover the meaning of a worsening renal function may be different depending
on the considered setting (acutely decompensated heart failure vs. chronic, renin
angiotensin aldosterone system inhibition (RAASi) use and uptitration, biphasic
temporal effect of SGLT2 inhibition on kidney function…).
 One may also wonder if changes in estimated glomerular filtration rate and/or
microalbuminuria should be considered as relevant biotargets and surrogates of
outcomes whilst assessing the cardiovascular benefit of a new compound and if
any, which outcome (cardiovascular or renal) should be prioritized for testing if
the compound exhibits cardiorenal effects.
 Finally, should we pay attention to a worsening in renal function under RAASi as
long as potassium concentrations are maintained in the normal range with a
potassium binder?
Welcome Remarks
Understanding and overcoming the challenges to involving patients with kidney
disease in cardiovascular trials: KHI Project Overview
Julie Ishida (San Francisco, USA)
· Involving patients with kidney disease in cardiovascular and diabetes trials
Lessons Learned and Future Directions
Charles Herzog (Minneapolis, USA)
· Are surrogate endpoints inevitable?
George Bakris (Chicago, USA)

Changes in GFR: How to assess? Reversible vs. irreversible, short – term vs.
long-term, and when are these good news, neutral news, or bad news?
Claudio Ronco (Vicenza, ITA)
Michael Felker (Durham, USA)
The Issue with competing risk and composite endpoints
Janet Wittes (Washington, USA)
Definitions of 'Worsening Renal Function' in cardiorenal trials. How to balance
sensitivity and specificity?
Patrick Rossignol (Nancy, FRA)
Should renal function ever be a primary efficacy endpoint or only a safety
endpoint in heart failure?
· Cardiologist viewpoint
Faiez Zannad (Nancy, FRA)
· Nephrologist viewpoint
Rajiv Agarwal (Indianapolis, USA)
Renal endpoints in the setting of CV prevention trials
· Hypertension
George Bakris (Chicago, USA)
· Diabetes Kidney Disease
o FIGARO – FIDELIO
Rajiv Agarwal (Indianapolis, USA)
o CREDENCE
Vlado Perkovic (Sydney, AUS)
· Regulatory viewpoint:
Angeles Alonso (EMA, GBR), Aliza Thompson (FDA, USA);
· Industry and CRO perspective:
Richard Nkulikiyinka (Bayer, GER); Barbara Gillespie (Covance, USA), Alain
Romero (Relypsa, USA); Jula Inrig (Quintiles, USA); Erica Caveney (Quintiles, USA)
· Patients’ perspective:
Cynthia Chauhan (Wichita, USA)

THE FORUM
Moderated discussion with the audience
Chairpersons: Prabir Roy- Chaudhury (Tucson, USA); Patrick Rossignol (Nancy, FRA)
Panelists: Rajiv Agarwal (Indianapolis, USA), Angeles Alonso (EMA, GBR), George
Bakris (Chicago, USA), Erica Caveney (Quintiles, USA), Cynthia Chauhan (Wichita,
USA), Michael Felker (Durham, USA), Barbara Gillespie (Covance, USA),
Charles Herzog (Minneapolis, USA), Jula Inrig (Quintiles, USA); Julie Ishida (San
Francisco, USA), Richard Nkulikiyinka (Bayer, GER), Vlado Perkovic (Sydney, AUS),
Alain Romero (Relypsa, USA), Claudio Ronco (Vicenza, ITA), Patrick Rossignol (Nancy,
FRA), Prabir Roy-Chaudhury (Tucson, USA), Aliza Thompson (FDA, USA); Janet Wittes
(Washington, USA), Faiez Zannad (Nancy, FRA)