Explore the Agenda
7:00 am Morning Check-In
7:55 am Chair’s Opening Remarks
Confronting Hidden Risks & Evolving Definition To Accelerate Breakthroughs In Kidney & Cardiorenal Care
8:00 am Panel Discussion: Advancing Drug Development in Cardiovascular-Kidney-Metabolic (CKM) Syndrome
- Explore our evolving understanding of the pathophysiology linking cardiovascular, kidney and metabolic disorders
- Identify when and how overlapping CKM phenotypes can be leveraged to design more efficient clinical trials
- Discuss next steps in integrated drug development and regulatory frameworks for CKM components with shared mechanistic drivers
8:30 am Charting the Future of CKD Care with Multi-Drug Combinations: One Size Fits All or One Fit for Each?
- Evaluating whether all patients require the full suite of therapies or tailored combinations based on individual risk and disease drivers
- Defining optimal sequencing strategies: RAS inhibition first, or starting with the most effective therapy for each patient?
- Exploring how combination regimens of 3+ drugs can be sequenced and optimized to balance efficacy, safety, and real-world practicality
- Considering how obesity, cardiorenal pathophysiology, and kidney structural injury inform future pharmacotherapy strategies
9:00 am From Genotype to Outcomes: RenasightIQ Real-World Evidence in Glomerular Diseases
- This presentation highlights real-world evidence from RenasightIQ to demonstrate how integrated clinical and genetic data are transforming risk stratification and treatment optimization in glomerular disease
- With focused insights from genetic ancestry, we will examine how genetic drivers influence disease trajectory and therapeutic response
- The session will also review real-world treatment effects of steroids/immunosuppression, ACE inhibitors/ARBs, and SGLT2 inhibitors
- Together, these findings underscore how precision medicine approaches can improve prognostic clarity, guide treatment decisions, and drive better patient outcomes
9:30 am Panel Discussion: How Can We Harness Hierarchal Composite Endpoints to Advance CKD Drug Design?
- The new Kidney HCE framework combines GFR slope, various thresholds of GFR decline (e.g. ≥ 40%, 50%, 57%), ESKD, and mortality in a hierarchical ordering to improve trial sensitivity and clinical relevance
- Regulatory bodies (NKF/FDA/EMA) are increasingly recognizing eGFR slope + albuminuria as valid surrogates, but the choice of thresholds, population, and follow-up duration remain critical
- Key methodological challenges include deciding component priorities, handling multiplicity, ensuring interpretability for patients
- Use-cases in broad CKD and rare subpopulations (e.g. IgA nephropathy) differ: design of HCEs must adapt thresholds, endpoints composition, and regulatory acceptability depending on disease, severity, and existing therapies
10:00 am Speed Networking
A prime chance to make the most of in-person networking and forge new connections as new companies enter, and existing ones broaden their presence within the CKD space. Designed to maximize your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the summit.
10:30 am Morning Break & Refreshments
Discovery, Preclinical, Translational Track
Designed for CSOs, preclinical researchers, discovery scientists, directors of biology and research, novel modality scientists, in vivo/in vitro modelling experts and many more fueling the next generation of CKD therapeutics
Track Chair:
INNOVATING ORGANOIDS & PRECLINICAL MODELS TO RECAPITULATE DIVERSE & HETEROGENOUS CKD PATHOLOGY
11:00 am Decoding CKD Progression Through Biomarkers, Models & Emerging Mechanisms
- Leveraging validated biomarkers to accelerate preclinical target discovery and therapeutic decision making
- Using single-cell data to reveal how tubular, endothelial, inflammatory, and fibroblast cells drive disease
- Advancing in vivo models such as the db/db UNX renin AAV to explore incretin-based therapies for kidney health
11:30 am Rodent Models of ANCA-Associated Nephritis
- Experimental autoimmune vasculitis models with nephritis induction: challenges and considerations
- Strategies for inducing passive and active MPO-AAV Nephritis for pre-clinical research
11:40 am Translating Natural Models of Disease Resistance and Regeneration into Novel Therapeutic Modalities in Cardiorenal & Metabolic Disease
- How natural biology of hibernators mimic chronic/acute kidney injury (AKI) and observing how renal tissues recover function despite damage that occurs every two weeks over a 6 month hibernation cycle
- How spiny mice (Acomys) regenerate severely injured nephrons without fibrosis and what gene signatures / transcription-programs underlie that response
- Insights from camel kidney studies: how extreme dehydration followed by rapid rehydration modulates oxidative stress, apoptosis, expression of aquaporins and solute carrier (SLC) proteins, and preserves kidney cortical/medullary structure
- Strategies for leveraging organismal resilience to derive robust human kidney signatures, in parallel with programs in heart failure and obesity (e.g. with Eli Lilly), to identify novel therapeutic targets
12:10 pm The Spontaneously Diabetic Torii (SDT) Fatty Rat, a New Model of Cardiovascular-Kidney-Metabolic (CKM) Syndrome
- While most of mouse and rat models have several limitations, the SDT fatty rat represents a novel and translatable alternative to model CKM
- Exploring the effect of GLP-1r based therapies to demonstrate the translatability of the SDT fatty rat for evaluating new therapies targeting CKM
12:20 pm Roundtable Discussion: Blue Sky Thinking: What is the Roadmap for Designing Next Generation Kidney Organoids that Better Recapitulate Kidney Function & CKD Pathology?
- How can we generate functional data to assess the function of different cell types in kidney organoids
- How can we recapitulate filtration in kidney organoids and proximal tubules that are immature and don’t do transport
- How can we engineer cells so that function better resembles kidney function
Clinical, Innovation, Regulatory & Outcomes Track
Tailor-made for medical directors, CMOs, clinical program leads, regulatory affairs professionals, access, reimbursement & HEOR colleagues, BD experts, clinicians and more; share expertise from diverse clinical challenges and innovation in CKD
Track Chair:
SMARTER ENDPOINTS, BIOMARKERS & ADAPTIVE STRATEGIES TO ADVANCE CKD CLINICAL DEVELOPMENT
11:00 am Optimizing CKD Outcomes Through Fixed-Dose Combination Therapies
- Evaluating clinical rationale for combining complementary mechanisms in a single therapy to improve kidney and cardiovascular outcomes
- Reviewing evidence from recent trials demonstrating efficacy, safety, and tolerability of fixed-dose combinations in CKD populations
- Considering regulatory and formulation challenges for developing multi-agent therapies with predictable pharmacokinetics
- Exploring patient adherence, convenience, and real-world implementation benefits of fixed-dose combination strategies
11:30 am Multi-Organ MRI Enables Smarter, Mechanism-Driven CKLM Trials
- Label expansion is accelerating across CV, CKD, HFpEF and MASH, and CKLM trials would benefit from measuring cross-organ response, not just weight or eGFR
- Ectopic fat imaging (renal, cardiac, pancreatic, hepatic) quantifies cardiometabolic risk and treatment response at the tissue level
- Multi-organ inflammation, fibrosis and perfusion biomarkers capture therapeutic benefit beyond fat loss, enabling earlier readouts and stronger regulatory narratives
12:00 pm CAPTIVATE: Innovating Adaptive Platform Trial Design to Slow CKD Progression
- Employing the Global Kidney Patient Trials Network (GKPTN) registry to pre-identify and enroll over 4,300 non-dialysis CKD patients across 8 countries, enabling more representative baseline data
- Using an adaptive platform, multifactorial, phase III trial structure allowing addition/removal of therapeutic agents and domains – starting with a mineralocorticoid receptor antagonist vs placebo
- Targeting slowing of eGFR decline as the primary endpoint, powered via Bayesian simulations
- Building in flexibility through the “eternal” trial design (ongoing recruitment and follow-up), enabling testing of combination treatments and evolving interventions over time
12:30 pm Anti-CD38 Plasma-Cell Depletion in IgA Nephropathy: 2-Year Clinical Insights & the Case for Durable, Finite Dosing
- Reviewing of 2-year follow-up data demonstrating sustained proteinuria reduction and eGFR stabilization after limited antiCD38 dosing
- Mechanistic rationale for targeting long-lived plasma cells to achieve durable immunologic and clinical remission
- Clinical and practical implications of finite treatment duration versus chronic dosing in IgA nephropathy management
- Broader applicability of anti-CD38 approaches across antibody-mediated kidney diseases and future development considerations
1:00 pm Lunch & Networking
Discovery, Preclinical & Translational Track
Designed for CSOs, preclinical researchers, discovery scientists, directors of biology and research, novel modality scientists, in vivo/in vitro modelling experts and many more fueling the next generation of CKD therapeutics
ADVANCING PRECISION GLOMERULAR & CKD CARE THROUGH AUTOANTIBODY INSIGHTS, TRANSCRIPTOMICS & NEXT‑GENERATION BIOMARKER STRATEGIES
2:00 pm Advancing Glomerular Disease Care Through Autoantibody Biomarkers
- Highlighting the role of podocyte-targeting autoantibodies in monitoring disease activity and guiding treatment decisions
- Exploring novel biomarkers to enable earlier intervention and more precise therapeutic strategies
- Showcasing global centers of excellence and international collaborations in autoimmune glomerular disease research
- Discussing implications for pharmaceutical development and opportunities to accelerate drug discovery and clinical translation
2:30 pm Roundtable Discussion: Transcriptomic & Biomarker Strategies for Navigating Residual Risk (Separating Responders & Non-Responders & Determining Combination Therapy Success) in CKD
- Mapping patient biology with transcriptomics and panels of biomarkers to identify gaps in disease mechanisms that aren’t being rescued/treated by current drugs in the landscape
- Translating these gaps in biology to identify molecular and clinical markers that distinguish responders from non-responders to existing therapies
- Evaluate potential benefits and risks of combination regimens (e.g., SGLT2 + GLP-1) based on patient phenotype
Clinical Innovation, Regulatory & Outcomes Track
Tailor-made for medical directors, CMOs, clinical program leads, regulatory affairs professionals, access, reimbursement & HEOR colleagues, BD experts, clinicians and more; share expertise from diverse clinical challenges and innovation in CKD
UNITING EMERGING RENAL THERAPIES WITH MODERN COMPOSITE ENDPOINTS TO ELEVATE CLINICAL RELEVANCE IN CKD TRIALS
2:00 pm Leveraging Hierarchical Composite Endpoints to Capture Meaningful Outcomes in CKD Trials
- Defining the role of hierarchical endpoints in addressing heterogeneity in CKDoutcomes
- Designing trials that balance regulatory rigor with clinical relevance
- Case examples of composite endpoint application in recent CKD studies
- Best practices and pitfalls when perationalizing hierarchical outcome measures
2:30 pm A Novel Potential Therapy for Alport Syndrome with Applicability in Multiple Rare & Common Renal Diseases
- Phase 2 “ALPESTRIA-1” trial demonstrated significantly reduced albuminuria and reversed the expected decline in kidney function with durable effects after treatment discontinuation in Alport syndrome
- Targeted effects on inflammation and fibrosis, downstream of causal mutational changes and hallmarks of most CKD, may be relevant for other diseases such as ADPKD
- A third trial, in CKD/DKD associated with MASH, studies a new indication opportunity for fast-follower compound EYP651
3:00 pm Afternoon Break & Refreshments
Building Partnerships & Patient-Centered Trials to Transform CKD Research
3:30 pm Advancing CKD Clinical Trials via Adaptive Platforms: Novel Endpoints, Basket Strategies & Collaborative Frameworks
- Explore how adaptive platform trials can strengthen nephrology research by creating sustainable infrastructures that support multiple sponsors, consistent site engagement, and faster patient recruitment
- Examine emerging alternatives to traditional eGFR slope endpoints, including hierarchical composites and win ratios, to deliver more clinically meaningful and regulator-acceptable outcomes
- Discuss how umbrella and basket trial designs can integrate CKD and cardiovascular populations to drive efficiencies and shared insights across comorbid conditions
- Consider how collaboration between industry, regulators, and investigators can overcome perceived risks of platform trials, facilitate indication-seeking studies, and enable broader access to patient populations
4:00 pm From Preclinical Pathway to Commercialization: Integrating the CKD Patient Voice at Every Stage of Drug Development
- Embedding patient advocacy organizations from preclinical pathway selection through to commercialization to ensure patient-centred design
- Co-developing study protocols informed by large-scale patient surveys and real-world insights to strengthen trial relevance
- Engaging patients early to refine endpoints, inclusion criteria, and study feasibility based on lived experience
- Creating ongoing partnerships between patients, scientists, and sponsors that inform both trial governance and long-term development strategy
4:30 pm An Investigational B-Cell Modulator for the Treatment of Autoimmune Renal Disease
- Discuss the central role of B-cells, BAFF and APRIL in the pathophysiology of IgAN
- Review the MOA of atacicept and its potential role in IgAN and other antibody mediated glomerular disorders
- Provide and overview of the ORIGIN atacicept clinical development program including recent phase 3 data
5:00 pm GFR Assessment at the Point of Care: Future Transdermal GFR (tGFR) Applications in the Clinic
- Overview of the Transdermal GFR System (TGFR) including review of the transdermal GFR (tGFR) methodology, indication for use and patient care path
- Retrospective analysis of mGFR (relmapirazin) and tGFR data as it compares to the Standard of Care in current clinical practice
- Focused clinical use cases including a description of the unmet medical need and anticipated TGFR study design in specific patient sub-populations
- Future TGFR developments
5:30 pm Making CKD Clinical Trials More Accessible, Feasible & Patient-Centered: Bridging Research Goals with Real-World Realities
- Understanding the broader patient experience from both patient, caregiver and clinician perspective
- Exploring the decision to participate in a clinical trial, and factors that may limit patient involvement
- Examining strategies to make trials more accessible to patients including geographical, financial and logistical barriers, while fostering open communication between researchers and participants
- Reducing burden for patients to participate in a clinical trial through innovative strategies
6:15 pm Chair’s Closing Remarks
6:20 pm Drinks Reception & Scientific Poster Session
This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of preclinical, translational, and clinical scientists eager to hear the latest advancements in kidney therapeutic development, you will have the opportunity to display a poster presenting your own work and innovations, while unwinding with a complimentary drinks reception, hosted by Natera.