8:25 am Chair’s Opening Remarks
What Is the Next Step After SGLT2 Inhibitors? Complementing the New Standard of Care
8:30 am Predicting Future Standard of Care with SGLT2 Inhibitors to Design Relevant Clinical Trials
Synopsis
- What will the standard of care look like in drug development for CKD?
- Designing trials that will allow for the inclusion of novel therapies alongside SGLT2 inhibitors
- Considering the future standard of care: combining SGLT2 inhibitors with multiple therapies
9:00 am Challenges for Trials in the New SGLT2i Landscape
Synopsis
- Generating evidence when standard of care might not be real world delivered care
- Role of new endpoints and alternative designs in trial efficiency
- Identifying fast progressors to streamline clinical trials
9:30 am Panel Discussion: Identifying & Validating a Novel Therapy to Complement SGLT2 Inhibitors
Synopsis
- Defining the next wave of therapeutics discovery after SGLT2i to improve clinical outcomes
- Measuring incremental benefit of novel therapeutics in addition to SGLT2 inhibitors
- Optimizing a smart preclinical screening platform to monitor efficacy in addition to standard of care
- Considering innovative trial design and untraditional endpoints to demonstrate efficacy and meet regulatory requirements
10:00 am Morning Break & Networking
Leveraging In Vivo & In Vitro Models to Predict Target Engagement & Understand Disease Mechanisms
11:00 am Exploring Complex 3D Models to Illuminate Disease Mechanisms & Predict Therapeutic Efficacy
Synopsis
- Evaluating next-generation models to understand translational potential for kidney disease
- Expanding the use of reproducible and easily modulated 3D cultures to model interactions between different tissue types
- Leveraging advances in organ-on-a-chip technologies and 3D bioprinting to mimic human physiology
11:30 am Interrogating Translatability of In Vitro to In Vivo Models to Select Appropriate Kidney Models & Predict Efficacy
Synopsis
- Acute Kidney Injury (AKI): How does the multitude of AKI models relate to patient disease?
- Which readouts matter the most?
- Could cellular assays help to optimize the in vitro to in vivo models translatability?
12:00 pm Using Animal Models of Chronic Kidney Disease to Inform Drug Discovery & Mechanisms of Action
Synopsis
- Evaluating differential drug responses in animal models of chronic kidney disease
- Using genetically modified mouse models to enable mechanistic understanding of kidney disease
- Employing omics platforms to characterize models that are most relevant to specific disease etiology
Innovating Clinical Trial Design to Engage Patients & Optimize Study Outcome
11:00 am Implementing Decentralized & Patient- Centric Approaches to Clinical Trials to Improve Patient Outcomes & Accelerate Clinical Development
Synopsis
- What have we learned from shifting to clinical trials during the pandemic?
- Establishing a logistical framework for operationalizing decentralized clinical trials: where are the opportunities to innovate?
- Adopting alternative clinical trial designs to evaluate multiple interventions
11:30 am Moving the Needle on Decentralized Trial Design & Real World Evidence
Synopsis
- Integrating real-world evidence into clinical trial design to establish efficacy
- Screening, recruitment, monitoring and follow up: implementing remote monitoring and visits in clinical trials
- Regulatory considerations for decentralized trials and implementing real world evidence
12:00 pm AFFINITY: A Phase 2 Basket Trial to Study the Safety & Efficacy of Atrasentan in Multiple Proteinuric Glomerular Diseases
Synopsis
- Evolving opportunities in developing basket trials to accelerate efforts to tailor effective therapies to different disease subgroup of patients most likely to respond
- Optimizing clinical trial procedures and infrastructure
- Assessing patient inclusion criteria to optimize data
12:30 pm Lunch & Networking
1:30 pm Examining the Interaction Between Mechanical Stress & Podocyte Defects in Chronic Kidney Disease
Synopsis
- Assess organs-on-chip technology to study chronic kidney disease, particularly the effects of mechanical stresses on podocytes
- Looking to the future: personalizing organs-on-chips for precision medicine and drug screening
1:30 pm Toward More Patient-Centered Clinical Trial
Synopsis
- Learnings from patient-focused drug development workshops on rare kidney diseases
- An interactive, web-based CKD patient registry
- Enhancing patient-centricity in clinical trial design to enhance patient participation
Confronting Patient Recruitment: How can we get the Right Patients into Trials?
2:00 pm Panel Discussion: Championing Enrolment of Underserved & Underrepresented Patient Populations
Synopsis
- Exploring opportunities to tackle lack of trust in healthcare and clinical trials
- Ensuring patient population is representative of the target population
- Deepening our understanding and efforts toward patient-centricity in trial design for underrepresented patient populations
2:30 pm Addressing the Unknown Causes of Kidney Diseases: A Roadmap for Change
Synopsis
- Overview of the current data discussing the percentage of cases of kidney disease of unknown etiology
- Review the impact of barriers to accurate, early diagnosis of kidney disease cause on patient outcomes, particularly patients of color
- Highlight the need for increased awareness and testing for rare and genetic diseases that impact the kidneys
- Discuss a consensus document for addressing barriers through development of data-driven solutions for policy, patient and professional-facing interventions
3:00 pm Afternoon Break & Networking
Dissecting Clinical Updates to Influence the Next Generation of Trials
3:30 pm Designing & Implementing a Robust Clinical Program For Anaemia in CKD & Update on Clinical Data
Synopsis
- Study design considerations development of drugs for anaemia caused by chronic kidney disease
- Explore the adaptations of study design and execution in the time of COVID – lessons learned for the future conduct of clinical studies
- Get an update on clinical data for the phase 3 studies for Daprodustat
4:00 pm Neutralization of APRIL with BION-1301: A Targeted, Potentially Disease-Modifying Approach to IgA Nephropathy
Synopsis
- Learn how excess production of galactose-deficient IgA1 (Gd-IgA1) by IgA secreting plasma cells is considered the initiating pathogenic event (Hit 1) in IgAN
- Hear about PRoliferation Inducing Ligand (APRIL), a TNF-family cytokine that drives IgA class-switching, survival of IgA-secreting plasma cells and stimulates Gd-IgA1 secretion
- Explore how BION-1301, a novel humanized monoclonal antibody that binds and blocks APRIL, has demonstrated initial validation of this targeted mechanism in patients with IgAN in a Phase 1/2 clinical study
4:30 pm Discovery & Development of Tenapanor for the Treatment of Hyperphosphatemia in Patients with CKD on Dialysis: A Novel Blocker of Paracellular Phosphate Absorption
Synopsis
- Physiology of phosphate homeostasis and the cardiovascular sequelae of hyperphosphatemia in patients with kidney disease
- New mechanistic understandings of phosphate absorption and control
- Clinical development of tenapanor as a novel blocker of paracellular phosphate absorption