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)

Speakers (10 minutes each):

• Academic perspective: Jonathan Himmelfarb (Mount Sinai, USA) - Innovative Renal Replacement Approaches

Discussants (5 minutes each):

• Renal LifeCycle Study: Christoph Wanner (Würzburg, GER)

• Academic perspective: Abhinav Sharma (Montreal, CAN)

• Academic perspective - Latest insights from the ADAPT trial: James Tumlin (Chattanooga, USA)

• FDA-CDER: Aliza Thomson

Panel discussion with all the above

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

Discussant (5 minutes):

Patient Perspective: Caroline Wilkie (National Kidney Foundation, USA) - Vascular Access is my Lifeline.

Speakers (10 minutes each):

• Academic perspective: Robert Lee (Michigan, USA) - Clinical Trial Designs for Vascular Access Trials

Discussants (5 minutes each) :

• Academic perspective: Vandana Niyyar(Emory, USA) - Choosing the Right End Point for the Right Device

• Academic perspective: Prabir Roy-Chaudhury (University of North Carolina, USA) - Precision Medicine Approaches to Vascular Access Care

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

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

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

• FDA: Aliza Thompson

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 Foundation)

Speaker (10 minutes) :

• 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

Moderator: Adeera Levin (Vancouver, CAN)

Speakers (10 minutes each):

• Pediatrician : Howard Trachtman (Michigan, US)

• Academic perspective: Mathias Kretzler (Ann Arbor, USA)

Discussants (5 minutes each):

• Academic perspective: Josef Coresh (Baltimore, USA)

• Academic perspective: Adeera Levin (Vancouver, CAN)

• Industry perspective: Marvin Sinsakul (AstraZeneca, USA)

• Industry perspective: Gordana Atanackovic (Bayer, USA)

• Industry perspective: Jennifer McKenzie (Boehringer Ingelheim, USA)

• FDA: Delphine Nelson

• FDA: Kirtida Mistry

Panel discussion with all the above

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

Discussant (5 minutes):

• Patient Perspective: Glenda Roberts (Mt. Sinai, USA) - Who Should we Test These Novel Therapies On?

Speakers (10 minutes each):

• Academic perspective - Kidney Regenerative Approaches: Joseph Bonventre (Harvard, USA)

• Academic perspective - Clinical Trial Design for Xenotransplantation: Vineeta Kumar (University of Alabama, USA)

Discussants (5 minutes each):

• Academic perspective: Mark David Lim (Washington, USA)

• Industry perspective: Mike Curtis (CEO, eGenesis)

• CBER - Clinical considerations and regulatory pathways for xenotransplantation: Jacob Little, MD, MS

• CBER - Learnings from xenotransplants to date: Vijay Kumar, MD, MMM

In the lobby of the Maison Française

Moderators: Tom Greene (Salt Lake City, USA)

Defining the objectives of a clinical trial is crucial to align design, analysis, and interpretation. With the recent release of an addendum to the E9 guideline on 'Statistical principles in clinical trials' by the International Council of Harmonization (ICH), regulatory agencies require the specification of estimand(s) which precisely describe the treatment effect(s) of interest in the study protocol. In this session the integration of estimands into kidney disease trials from both clinical and statistical perspectives will be explored. Clinically, estimands allow for more accurate measurement of treatment effects by incorporating so-called intercurrent events such as treatment discontinuation or use of rescue medications. Statistically, estimands need to be aligned with analytical methods, ensuring that sensitivity analyses are robust and account for missing data. This approach enhances the interpretability of trial results, improving decision-making in nephrology research and regulation. 

Speakers (10 minutes each):

• Statistician’s perspective: Tim Friede (Göttingen, GER)

• Academic perspective: Jule Pinter (Würzburg, GER)

Discussants (5 minutes each):

• Statistician’s perspective: Janet Wittes (Washington, USA)

• Industry statistician’s perspective: Fred Yang (KBP, US)

• Industry statistician’s perspective:  Svenja Seide (Boehringer Ingelheim, GER)

• Industry statistician’s perspective: Christopher Bush (Novartis)

• FDA: Dali Zhou (Biometrics)

Panel discussion with all the above

In the lobby of the Maison Française

In the Lobby of la Maison Française

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

Speaker (15 minutes):

• Academic perspective: Jürgen Floege (Aachen, GER)

• Academic perspective: Jonathan Barratt (Leicester, GBR)

• Academic perspective: Dana Rizk (Birmingham, USA )

Discussants (5 minutes each):

• Industry perspective: Jeffrey Hafkin (Otsuka)

• Industry perspective: Jay Garg (Genentech)

• Industry perspective: Radko Komers (Travere, USA)

• Industry perspective: Kerry Cooper (Vera Therapeutics, USA)

• Industry perspective: Stephen Nolan (Alexion Pharmaceuticals)

• FDA: Nadia Chaudhri

• EMA: Frank Holtkamp

Panel discussion with all the above

In the lobby of la Maison Française

Moderators: Matthew Weir (Baltomore, USA) & Hiddo Heerspink Lambers (Groningen, NED)

Having established relevant endpoints for IgAN (with already several drugs approved), and now FSGS,  membranous nephropathy coming next, must  specific endpoints be considered for each  glomerular disease vs generic core outcomes ? Potentially implemented in platform trials ?

Discussant (5 minutes ):

• Patient’s perspective: Josh Tarnoff (NephCure, USA)

Speakers (10 minutes each):

• Insights from the PARASOL initiative: Brad Rovin (Colombus, USA)

Discussants (5 minutes each):

• Academic perspective: Matthias Kretzler (Ann Arbor, USA)

• Academic perspective: Jerome Rossert (Boston, USA)

• KHI perspective: Uptal Patel (KHI, USA)

• Industry perspective: David Fuller (Dimerix)

• Industry perspective: Dominik Steubl (Boehringer-Ingelheim)

• Industry perspective: Jay Garg (Genentech)

• FDA: Austin Hu

• CMS: Frank Holtkamp

Panel discussion with all 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)

• 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

Moderator: Mathieu Legrand (San Francisco, USA)

• Update on the methods for COS generation: Mathieu Legrand (San Francisco, USA)

• Results of the literature review: Bruno Garcia(Brussels, BEL)

• Pediatric specificities: Natalja Stanski (Cincinnati, USA)

• Panelist: Sean Bagshaw (Edmonton, CAN)

• Panelist: Patrick Rossignol (Monaco, MON)

• Panelist: Dana Fuhrman (Pittsburgh, USA)

• Panelist: Ravindra Mehta (San Diego, USA)

• Panelist: Marlies Osterman(London, GRB)

• Panelist: Jay Koyner(Chicago, USA)

• Panelist: D’Arcy Duquette (Calgary, CAN)

• Panelist: Giovanni Landoni (Milan, ITA)

• Panelist: Alexander Zarbock(Münster, GER)

• Panelist - Industry perspective: Kai Riecke (Bayer, GER)

• Panelist - CMS perspective: Aliza Thompson

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