Arrival to the Embassy of France

Introduction by KDCT Course Director Professor Patrick Rossignol (Monaco, MON)

Moderator: Prabir Roy-Chaudhury (Chapel Hill, USA)

Discussant (5 minutes):

Patient Perspective: Nichole Jefferson (Home Dialyzors United, USA) - Why we need more Patient Centered Innovation

Speaker (10 minutes):

• Academic perspective: Jonathan Himmelfarb (Mount Sinai School of Medicine, NY, USA) - Innovative Renal Replacement Approaches: the future is here...

• Academic perspective: Christoph Wanner (Würzburg, GER and Oxford, UK) - The Renal Life Cycle Study: Targeting inflammation and fibrosis in Kidney Replacement Therapy patients: Rationale and Impact

Discussants (5 minutes each):

• Academic perspective: James Tumlin (Emory University, GA) - Clinical Trial Barriers in Hemodialysis Patients: Lessons from the ADAPT Study

• Academic perspective: Abhinav Sharma (McGill University, CAN) - Optimizing CV Outcomes using Digital Health Technology: Opportunities in Dialysis Patients

• Industry perspective: Peter Rutherford (Vantive) - What Next: Future Innovations and Clinical Trials in Peritoneal Dialysis

• FDA-CDER: Aliza Thomson

Panel discussion with all the above

Moderator: Prabir Roy-Chaudhury (Chapel Hill, USA)

Discussant (5 minutes):

Patient Perspective: Caroline Wilkie (Punta Gorda, FL) - Vascular Access is my Lifeline

Speakers (10 minutes each):

• Academic perspective: Robert Lee (Echelon Consulting, Grosse Pointe MI) - Clinical Trial Designs for Vascular Access Trials

• Academic perspective: Vandana Niyyar (Emory University, Atlanta, GA, USA) - Choosing the Right End Point for the Right Device in order to do the Right Trial

Discussants (5 minutes each):

• Academic perspective: Prabir Roy-Chaudhury (University of North Carolina, Chapel Hill, NC, USA) - Coordinated Registry Networks for Vascular Access Innovation

• Academic perspective: Joseph Singapogu (Clemson University, Clemson, SC, USA) - Clinical Trial Designs for Cannulation Simulators

• Academic perspective: Jeffrey Lawson (Duke University, Durham, NC, USA) - Arteriovenous Access Clinical Trials-Challenges and Opportunities

• Academic perspective: Antony E. Pfaffle (CorMedix, New York City, NY, USA) - Performing Dialysis Catheter Clinical Trials: Do’s and Dont’s

Panel discussion with all the above

In the lobby of the Maison Française

Moderators: Lesley Inker (Boston, USA) & Amy Mottl (Chapel Hill, USA)

Discussant (5 minutes):

• Patient perspective: Kerry Willis (National Kidney Fondation)

Speakers (10 minutes each):

• Academic perspective: Lesley Inker(Boston, USA)

• Academic perspective: Tom Greene (Salt Lake City, USA)

Discussants (5 minutes each):

• Academic perspective : Niels Jongs (Groningen, NED)

• Academic perspective: Tim Friede (Göttingen, Germany)

• Industry perspective: Dustin Little (Astra Zeneca)

• Industry perspective: Julie Funch Furberg(Novo Nordisk)

• FDA: Jialu Zhang, Dali Zhou, William Koh, Rekha Kambhampati, Aliza Thompson

Panel discussion with all the above

In the lobby of the Maison Française

Moderators: Meg Jardine (Sydney, AUS) & Christoph Wanner (Würzburg, GER)

Treatment exposure in routine care is routinely less than that in the trials supporting indications. Should we, and how would we, create incentives to generate evidence on uptake and adherence? How does implementation research supports patients in getting access to new treatments

Discussant (5 minutes):

Patient Perspective: Steven Macari (Naintré, FRA)

Speaker (10 minutes):

• Academic perspective: Sylvia Rosas (Boston, US)

Discussants (5 minutes each):

• Academic perspective: Janani Rangaswami (Washington DC, USA)

• Academic perspective: Meg Jardine (Sydney, AUS)

• Academic perspective: William Lawrence (PCORI)

• Academic perspective: Alain Romero (San Francisco, USA)

• Academic perspective: Grant Huang (Washington DC, USA)

• Industry perspective: Katja Rohwedder (Bayer)

• Industry perspective: Juliane Meyerhoff (Boehringer-Ingelheim)

Panel discussion with all the above

Moderator: Adeera Levin (Vancouver, CAN) & Professor Patrick Rossignol (Monaco, MON)

Several therapies are at the horizon to further improve kidney function and cv outcomes  such as new MRAs, aldosterone synthase inhibitor , soluble gyuanylate cyclase activators/stimulators, endothelin antagonists: how to use these therapies in practice? All together or personalized care ? Designing trials for the current era (multiple agents/ multiple actions) which trials are warranted to get this demonstrated ?

Discussant (5 minutes):

Patient Perspective: Patrick Gee (Richmond, USA)

Speakers (10 minutes each):

• Academic perspective: Meg Jardine (Syndey, AUS)

• Academic perspective: Hiddo Heerspink Lambers (Groningen, NED)

Discussants (5 minutes each):

• Academic perspective: Christoph Wanner (Würzburg, GER)

• Academic perspective: Sradha Kotwal (Sydney, AUS)

• Academic perspective: Christopher Wilcox (Washington D.C., USA)

• Academic perspective: Matthew Weir (Baltimore, USA)

• Industry perspective: Dustin Little (AstraZeneca, USA)

• Industry perspective: Michaela Petrini (Boehringer-Ingelheim)

• Industry perspective: Christopher Lettieri (Idorsia)

• NIDDK: Ivonne Schulman

• FDA: Nadia Chaudhri

Panel discussion with all the above

In the lobby of the Maison Française

Moderators: Christoph Wanner (Würzburg, GER)

Speakers (10 minutes each):

• Academic perspective: Beatriz Fernandez-Fernandez (Madrid, Spain)

Discussants (5 minutes each):

• Academic perspective: Navdeep Tangri (University of Manitoba, CAN)

• Academic perspective: Marc Froissart (Lausanne, SUI)

• AKI perspective: Jay Koyner (Chicago, USA)

• Editor perspective: Flavia Geraldes (The Lancet)

• CRO perspective: Barbara Gillespie (Fortrea, USA)

• Industry perspective: Martin Cowie (Astra-Zeneca) 

• Industry perspective: Len A. Usvyat (Fresenius Medical Care)

• NIDDK: Ivonne Schulman

Panel discussion with all the above

In the lobby of la Maison Française

In the Lobby of la Maison Française

Moderators: Dana Fuhrman (Pittsburgh, USA), Ravindra Mehta (San Diego, USA) & Matthieu Legrand (San Francisco, USA)

Speaker (15 minutes):

• Academic perspective: Giovanni Landoni (Milan, Italy)

Discussants (5 minutes each):

• Academic perspective: Alexander Zarbock (Münster, Germany)

• Academic perspective: Marlies Osterman(London, UK)

• Academic perspective: Chirag Parikh (Baltimore, USA)

• Industry perspective: Juliane Bernholz (AM-Pharma, NED)

• Industry perspective: Kai Riecke (Bayer, GER)

• Industry perspective: Michael Reusch (Guard Therapeutics, SWE)

• FDA perspective: Rekha Kambhampati

Panel discussion with all of the above

In the lobby of la Maison Française

Moderators: Kianoush Kashani (Rochester, USA) & Kathleeen Liu (San Francisco, USA)

Discussant (5 minutes):

Patient Perspective: D’arcy Duquette (Calgary, CAN)

Speakers (15 minutes each):

• Academic perspective: Sean Bagshaw (Edmonton, CAN)

Discussants (5 minutes each):

• Academic perspective: Ravindra Mehta (San Diego, USA)

• Academic perspective: Dana Fuhrman (Pittsburg, USA)

• Academic perspective: Jay Koyner (Chicago, USA)

• Industry perspective: Amit Sharma (Executive Vice President for Clinical Development, Vera Therapeutics, USA)

Panel discussion with all of the above

Moderators: Adeera Levin (Vancouver, CAN) & Christoph Wanner (Würzburg, GER)

Speakers (10 minutes each):

• Platform Trial: Sradha Kotwal (Sydney, AUS)

• Academic perspective: Meg Jardine (Sydney, AUS)

Discussants (5 minutes each):

• Academic perspective: Vlado Perkovic (Sydney, AUS)

• Academic perspective: Brad Rovin (Colombus, USA)

• How industry and academia are working together in platform trials: Heather Ascani (Michigan, USA)

• Academic perspective: Hiddo Heerspink (Groningen, NED)

• Insights from Covid platform trials: Yves Rosenberg (NHLBI, USA)

• Feedback on the Solidarity WHO sponsored platform trial : perspective from an academic CRO: Marc Froissart (Lausanne, SUI)

•  AKI (TBD)

• Academic funder perspective: William Lawrence(PCORI)

• Industry perspective: Martin Cowie (Astra-Zeneca)

• Industry perspective: Meike Brinker (Bayer)

• FDA: William Koh (Biometrics)

Panel discussion with all of the above

In the lobby of la Maison Française

Moderators: Hiddo Heerspink Lambers (Groningen, NED) & Vlado Perkovic (Sydney, AUS)

Downstream FLOW, are GLP-1 RA alone sufficient or do we need more to further improve outcomes ? New nutrient stimulating hormone therapies may include dual GIP and GLP-1 receptor agonist (e.g tirzepatide), Glucagon/GLP-1RA,  Glucagon-GIP/GLP-1 RA: which trial design is warranted ? Regarding endpoints, how best assessing effects on kidney disease progression in the setting of substantial weight loss ?

Speakers (10 minutes each):

• Investigator’s perspective: Peter Rossing (Copenhagen, DEN)

• Academic perspective: Matt Weir(Baltimore, USA)

Discussants (5 minutes each):

• Academic perspective: Amy Mottl (Chapel Hill, USA)

• Academic perspective: Hiddo Lambert Heerspink (Groningen, NED)

• Industry perspective: Dominik Steubl (Boehringer-Ingelheim)

• Industry perspective: Thomas Idorn(Novo Nordisk, DEN)

• Industry perspective: Ibrahim Turfanda (Eli Lilly, USA)

• Industry perspective: Marvin Sinsakul (AstraZeneca, USA)

• Industry perspective: Bergur Stefansson (Roche)

• FDA: Rekha Kambhampati

Panel discussion with all of the above

Final words by Professor Patrick Rossignol and co-directors, and adjourn