Connecting Research Communities
As a global leader committed to connecting kidney health communities to develop a stronger understanding of the management of kidney disease, the ISN organizes periodic meetings on special issues in international research of kidney disease.
The ISN’s PARADIGM meeting took place in Vancouver, BC, Canada, from November 22-23, 2024.
The meeting gathered clinicians, trialists, patient partners, regulators, and industry scientists to rethink current concepts of laboratory values in CKD populations, the value of patient reported outcomes, and trial designs in this space, while fostering a culture of clinical trials.
The program of work will be of benefit to all relevant stakeholders:
- Patients: improved tools and approaches to assess and treat changes in laboratory values that may or may not correlate with patient-reported outcome measures; renewed focus on patient-reported outcome measures
- Clinicians: improved understanding and renewed interest in understanding and approaching treatment strategies in CKD populations
- Researchers: renewed interest and excitement in novel trial designs and paradigms linking complex (patho) physiology with patient-oriented outcomes and drug mechanism of action
- Industry partners: improved design of trials and more nuanced questions, with emphasis on specific populations; there may be improved appropriate use of their medication/s
- Regulators: improved understanding of the value of novel paradigms/treatment approaches and molecules may inform regulatory requirements for existing and novel agents
- Shared benefits amongst all would include understanding the value of patient-reported outcome measures to support shared decision making in clinical practice and clinical trial design.
Recommendations from the meeting will be developed in 2025.
The meeting was supported by several organizations (in alphabetical order): Alexion AstraZeneca Rare Disease, Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, and Otsuka. Support for the patient-partner participation was provided by Can-SOLVE CKD Network and Michael Smith Health Research BC, BC Support Unit.
The ISN’s TRANSFORM meeting (TRAnslational Nephrology Science FOR new Medications) took place in Brussels, Belgium, from October 8-9, 2022.
The meeting gathered patients, clinical and academic researchers, regulators, and industry partners to:
- Report ISN Research Working Group activities describing the current landscape and future possibilities;
- Reach consensus on guidance that optimizes animal study design and drives the discovery of new drugs;
- Provide a platform for patients, clinical researchers, regulators, and industry partners to collaborate.
Recommended guidance for the international kidney care community has been published in Kidney International. Read it HERE.
Summary of all recommendations for preclinical animal studies in translational nephrology:
This meeting was made possible with support from partners, listed in alphabetical order:
AstraZeneca, Aurinia Pharma, Daiichi Sankyo, Kyowa Kirin, Otsuka Pharmaceutical Co. Ltd., and Travere Therapeutics.
A two-day meeting was held in Vancouver, Canada, from January 31 to February 1, 2020, which brought together the ISN executive leadership, members of ISN Research groups, patients, clinicians, clinical trialists, academics, industry, and regulators to establish momentum for international collaborative work in clinical trials and research in kidney disease across the world.
The meeting introduced current ISN research activities and described the overall landscape in international clinical research. Six patient partners shared their kidney journeys and their perspectives on participating in research. The focus of the meeting was to present, vet, and clarify draft definitions of kidney failure as endpoints in clinical trials, and to understand the nuances and issues related to different definitions, in specific circumstances, in order to achieve international consensus.
The International Consensus Definitions of Clinical Trial Outcomes for Kidney Failure: 2020 was published in Kidney International, which describes the recommended components of kidney failure endpoints for use in clinical trials, based on the totality of the work done by the conference participants.
This was the first attempt by the international nephrology community to identify reproducible, robust definitions of kidney failure outcomes and acceptable surrogates for clinical trials, to be used worldwide, in any resource setting. The value of these consensus definitions will be to improve consistency and understanding of results in clinical trials. This is a first step toward a long-term goal to improve the evidence base from which to treat patients with kidney diseases worldwide.
This meeting was made possible with support from partners, listed in alphabetical order:
AstraZeneca, Baxter, Bayer, Boehringer Ingelheim, Gilead, Janssen Inc. (a pharmaceutical company of Johnson & Johnson), Novo Nordisk, Otsuka, Reata Pharmaceuticals, and Retrophin (now Travere Therapeutics).
Held in Sharjah, UAE, in March 2018, the summit’s output was a high-level global strategy to improve universal access to integrated care for kidney failure, published as a Supplement to Kidney International.
Additional action plans were published in Kidney International Supplements on:
- Capturing and monitoring global differences in untreated and treated kidney failure, KRT modality, and outcomes;
- Developing a framework for establishing integrated kidney care programs in low and middle-income countries;
- Workforce challenges for sustainable care for kidney failure in low and middle-income countries;
- Developing a framework for minimum and optimal safety and quality standards for hemodialysis and peritoneal dialysis;
- Considering equity in the management of kidney failure in low and middle-income countries;
- Developing an ethical care framework for kidney failure: from practice to policy;
- The role of kidney transplantation as a component of integrated care; and
- Supportive care for kidney failure treatment across a range of income settings around the world.
15 case studies were developed documenting context-driven variability in approaches to kidney care across countries while demonstrating the potential advantages of multi-stakeholder engagement. These were included in the Kidney International Supplements publication elaborating the ISN’s action plans.
A Strategic plan for integrated care of patients with kidney failure based on the action plans above has been published in Kidney International. Selected activities are planned in conjunction with several partners to be implemented over the next 5 to 10 years.
In 2024, the Conservative Kidney Management/Kidney Supportive Care workgroup from the Strategic Plan published in Kidney International as part of their first project. See also the Kidney Supportive Care and Conservative Kidney Management Curriculum available on the ISN Academy.
The ISN Global Kidney Health Summit, the first meeting of its kind, took place in July 2016, in Vancouver, BC, Canada. The Summit gathered 85 international key opinion leaders and researchers to set in motion a roadmap for action to change the status of kidney health worldwide, building on current knowledge, research, and clinical activities. The Summit addressed CKD issues of global relevance. In the context of the ISN-GKHA, the connection between CKD and AKI was discussed as well as the link between kidney disease and cardiovascular and metabolic disorders. The roadmap stemming from these discussions was published in The Lancet, in April 2017. It identifies and prioritizes key activities for the next 5–10 years in clinical care, research, and advocacy.
In addition, Working Group papers addressing the following topics were published in Kidney International Supplements in October 2017:
- Action plan for determining and monitoring the prevalence of chronic kidney disease;
- Reducing major risk factors for chronic kidney disease;
- Genetic and environmental risk factors for chronic kidney disease;
- Strategies to improve monitoring disease progression, assessing cardiovascular risk, and defining prognostic biomarkers in chronic kidney disease;
- Closing the gap between evidence and practice in chronic kidney disease;
- Complications of chronic kidney disease: current state, knowledge gaps, and strategy for action;
- The establishment and validation of novel therapeutic targets to retard progression of chronic kidney disease;
- Action plan for optimizing the design of clinical trials in chronic kidney disease.
The ISN is uniquely positioned to lead this global initiative and is focused on delivering a renewed global commitment to improving standards of kidney care worldwide.