. 2025 Feb 14:12:20543581251318442.

doi: 10.1177/20543581251318442. eCollection 2025.

Cultivating Innovative, Pragmatic, Randomized Controlled Registry Trials Embedded in Hemodialysis Care: Conference Proceeding From Gardener's Grove 2023

Bryn Tannar¹, Patricia Olar¹, Shane Kilburn^{1

2}, Kathleen Brown-Blake^{1

2}, Ahmed A Al-Jaishi^{2

3}, Peter G Blake^{1

4

5}, Kristin K Clemens^{2

6

7

8}, Charles Cook⁹, Laura M Dember^{10

11}, Stephanie N Dixon^{1

2

6}, Cory E Goldstein^{12

13}, Areef Ishani^{14

15}, Catherine Joyes¹⁶, Conor Judge^{17

18}, James C Kaufman^{19

20}, Susan Q Mackenzie^{9

21}, Taylor McLinden^{1

2

6}, Amber O Molnar^{2

18}, Alicia Murdoch²², Gihad Nesrallah^{23

24}, Sanjay Pandeya^{25

26}, Claudio Rigatto^{25

27

28}, Pavel S Roshanov^{1

4

6

29}, Melissa Schorr^{1

18}, Samuel A Silver^{2

30}, Rona M Smith^{31

32}, Leanne Stalker³³, Navdeep Tangri^{27

28}, Monica Taljaard^{12

13}, Karthik K Tennankore³⁴, Hans Vorster⁵, Charles Weijer^{6

35

36}, Myles Wolf³⁷, Merrick Zwarenstein^{2

6}, Amit X Garg^{1

2

4

6

38}

Affiliations

¹ London Health Sciences Centre, ON, Canada.
² Institute for Clinical Evaluative Sciences, Kidney, Dialysis and Transplantation Research Program, London, ON, Canada.
³ Public Health Agency of Canada, Ottawa, ON, Canada.
⁴ Division of Nephrology, Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
⁵ Ontario Renal Network, Cancer Care Ontario, Toronto, Canada.
⁶ Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
⁷ Division of Endocrinology and Metabolism, Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
⁸ St. Joseph's Health Care London, ON, Canada.
⁹ Grand River Hospital, Transplant Ambassador Program, Kitchener, ON, Canada.
¹⁰ Division of Renal, Electrolyte, and Hypertension, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
¹¹ Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
¹² Clinical Epidemiology Program, Ottawa Hospital Research Institute, ON, Canada.
¹³ School of Epidemiology and Public Health, University of Ottawa, ON, Canada.
¹⁴ Minneapolis VA Health Care System, MN, USA.
¹⁵ Department of Medicine, University of Minneapolis, MN, USA.
¹⁶ Department of Clinical Research, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
¹⁷ Galway University Hospital, Ireland.
¹⁸ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
¹⁹ Division of Nephrology, Department of Medicine, Grossman School of Medicine, New York University, NY, USA.
²⁰ VA New York Harbor Healthcare System, NY, USA.
²¹ The Kidney Patient and Donor Alliance Canada, Calgary, AB, Canada.
²² Can-SOLVE CKD Network, Vancouver, BC, Canada.
²³ Temerty Faculty of Medicine, University of Toronto, ON, Canada.
²⁴ Department of Medicine, Humber River Health, Toronto, ON, Canada.
²⁵ Canadian Society of Nephrology, Winnipeg, MB, Canada.
²⁶ Halton Healthcare, Oakville, ON, Canada.
²⁷ Division of Nephrology, Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
²⁸ Chronic Disease Innovation Centre, Seven Oaks Hospital, Winnipeg, MB, Canada.
²⁹ Population Health Research Institute, Hamilton, ON, Canada.
³⁰ Division of Nephrology, Kingston Health Sciences Center, Queen's University, ON, Canada.
³¹ University of Cambridge, UK.
³² Cambridge University Hospitals NHS Foundation Trust, UK.
³³ The Kidney Foundation of Canada, National Office, Montreal, QC, Canada.
³⁴ Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, NS, Canada.
³⁵ Department of Philosophy, Western University, London, ON, Canada.
³⁶ Division of Critical Care Medicine, Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
³⁷ Division of Nephrology, Department of Medicine, Duke Clinical Research Institute, School of Medicine, Duke University, Durham, NC, USA.
³⁸ Victoria Hospital, London Health Sciences Centre, ON, Canada.

PMID: 39958603
PMCID: PMC11829301
DOI: 10.1177/20543581251318442

Cultivating Innovative, Pragmatic, Randomized Controlled Registry Trials Embedded in Hemodialysis Care: Conference Proceeding From Gardener's Grove 2023

Bryn Tannar et al. Can J Kidney Health Dis. 2025.

. 2025 Feb 14:12:20543581251318442.

doi: 10.1177/20543581251318442. eCollection 2025.

Authors

Affiliations

¹ London Health Sciences Centre, ON, Canada.
² Institute for Clinical Evaluative Sciences, Kidney, Dialysis and Transplantation Research Program, London, ON, Canada.
³ Public Health Agency of Canada, Ottawa, ON, Canada.
⁴ Division of Nephrology, Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
⁵ Ontario Renal Network, Cancer Care Ontario, Toronto, Canada.
⁶ Department of Epidemiology and Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
⁷ Division of Endocrinology and Metabolism, Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
⁸ St. Joseph's Health Care London, ON, Canada.
⁹ Grand River Hospital, Transplant Ambassador Program, Kitchener, ON, Canada.
¹⁰ Division of Renal, Electrolyte, and Hypertension, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
¹¹ Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
¹² Clinical Epidemiology Program, Ottawa Hospital Research Institute, ON, Canada.
¹³ School of Epidemiology and Public Health, University of Ottawa, ON, Canada.
¹⁴ Minneapolis VA Health Care System, MN, USA.
¹⁵ Department of Medicine, University of Minneapolis, MN, USA.
¹⁶ Department of Clinical Research, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
¹⁷ Galway University Hospital, Ireland.
¹⁸ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
¹⁹ Division of Nephrology, Department of Medicine, Grossman School of Medicine, New York University, NY, USA.
²⁰ VA New York Harbor Healthcare System, NY, USA.
²¹ The Kidney Patient and Donor Alliance Canada, Calgary, AB, Canada.
²² Can-SOLVE CKD Network, Vancouver, BC, Canada.
²³ Temerty Faculty of Medicine, University of Toronto, ON, Canada.
²⁴ Department of Medicine, Humber River Health, Toronto, ON, Canada.
²⁵ Canadian Society of Nephrology, Winnipeg, MB, Canada.
²⁶ Halton Healthcare, Oakville, ON, Canada.
²⁷ Division of Nephrology, Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
²⁸ Chronic Disease Innovation Centre, Seven Oaks Hospital, Winnipeg, MB, Canada.
²⁹ Population Health Research Institute, Hamilton, ON, Canada.
³⁰ Division of Nephrology, Kingston Health Sciences Center, Queen's University, ON, Canada.
³¹ University of Cambridge, UK.
³² Cambridge University Hospitals NHS Foundation Trust, UK.
³³ The Kidney Foundation of Canada, National Office, Montreal, QC, Canada.
³⁴ Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, NS, Canada.
³⁵ Department of Philosophy, Western University, London, ON, Canada.
³⁶ Division of Critical Care Medicine, Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
³⁷ Division of Nephrology, Department of Medicine, Duke Clinical Research Institute, School of Medicine, Duke University, Durham, NC, USA.
³⁸ Victoria Hospital, London Health Sciences Centre, ON, Canada.

PMID: 39958603
PMCID: PMC11829301
DOI: 10.1177/20543581251318442

Abstract
in English, French

Purpose of the conference: Hemodialysis is a life-sustaining treatment for patients with end-stage kidney disease. However, patients on dialysis continue to face poor quality of life and short life expectancies. Despite this, the nephrology community conducts the fewest randomized controlled trials of any medical discipline, relying instead on expert opinion to guide many aspects of hemodialysis care. There is a need to conduct high-quality pragmatic randomized controlled trials in hemodialysis to drive evidence-based practice. To this end, the Innovative Clinical Trials in Hemodialysis Centers initiative, with the support of the Canadian Institutes of Health Research and its Strategy for Patient-Oriented Research, funded the development of 6 pragmatic trial protocols. Gardener's Grove 2023 created a space to support the development of these trials and increase awareness and knowledge of past, ongoing, and future innovative, pragmatic, randomized controlled registry trials embedded in routine hemodialysis care. This report summarizes the proceedings of this conference.

Sources of information: The conference included 6 panel presentations, each featuring an overview of a new pragmatic trial followed by expert panel feedback from patient partners, nephrologists, researchers, and health care providers. The conference also included 10 educational sessions led by clinicians and researchers with experience in the fields of kidney medicine and clinical trials.

Methods: Gardener's Grove 2023 was a 4-day virtual conference held in March of 2023. Recordings of all the conference presentations were later published on the Gardener's Grove website and are summarized in the Supplemental Appendix of this report.

Key findings: The conference brought together 118 Canadian and international researchers, patients, and health care providers to collaborate on 6 pragmatic trials intended to test interventions to improve hemodialysis care. The proposed trials included (1) PREventing FracturEs in REnal Disease (PREFERRED), (2) DIALysis with EXpanded solute removal (DIALEX), (3) Sodium fOr diaLysis oUTcome rEduction (SOLUTE), (4) Finding the right blood pressure target for patients on dialysis, (5) DIuretic Use in patients with Residual renal function on hemodialysis (DIURESED), and (6) Lower vs higher dialysate bicarbonate concentration in patients receiving hemodialysis (Dial-Bicarb). All of these interventions were widely supported and received valuable feedback from panelists and conference attendees. The education sessions focused on various design and execution elements of pragmatic, randomized controlled registry trials embedded in routine care.

Limitations: The conference could have been improved by streamlining session topics and pacing, allowing additional time for discussions, strengthening online network opportunities, and improving survey response rates. A follow-up conference is planned to take place in a few years, and the coordinators will aim to implement these changes.

Implications: Gardener's Grove 2023 successfully created a space for patients, researchers, and health care providers to support the development of 6 new pragmatic trials in hemodialysis care. Since Gardener's Grove 2023, several of these trials have secured CIHR funding, obtained ethics approval, and are actively preparing to launch their interventions.

Objectifs de la conférence: L’hémodialyse est un traitement vital pour les personnes souffrant d’insuffisance rénale terminale. Les patients sous hémodialyse voient cependant leur qualité et leur espérance de vie réduites. Malgré cela, la communauté de la néphrologie est celle parmi toutes les disciplines médicales qui mène le moins d’essais contrôlés randomisés, s’appuyant plutôt sur l’opinion d’experts pour guider de nombreux aspects des soins d’hémodialyse. Des essais contrôlés, randomisés, pragmatiques de haute qualité sont nécessaires en hémodialyse pour encourager une pratique fondée sur des données probantes. C’est pourquoi l’Initiative sur les essais cliniques novateurs dans les centres d’hémodialyse, avec l’appui des Instituts de recherche en santé du Canada et de la Stratégie de recherche axée sur le patient, finance l’élaboration de six protocoles d’essais pragmatiques en hémodialyse. La conférence Gardener’s Grove de 2023 a créé un espace pour soutenir le développement de ces essais et accroître la sensibilisation et la connaissance sur les essais innovants, pragmatiques, randomisés et contrôlés—passés, en cours et futurs—intégrés dans les soins courants d’hémodialyse. Le présent rapport résume les travaux de cette conférence.

Sources de l’information: La conférence prévoyait six présentations de panel, chacune donnant un aperçu d’un nouvel essai pragmatique suivi des commentaires d’experts, de partenaires patients, de néphrologues, de chercheurs et de prestataires de soins. Dix séances de formation animées par des cliniciens et des chercheurs ayant une expérience en médecine rénale et en essais cliniques figuraient également au programme.

Méthodologie: Gardener’s Grove 2023 est une conférence virtuelle de quatre jours qui s’est tenue en mars 2023. Les enregistrements de toutes les présentations ont ensuite été publiés sur le site Web de Gardener’s Grove; ils sont résumés dans l’annexe supplémentaire du présent rapport.

Principaux résultats: La conférence a réuni 118 chercheurs, patients et prestataires de soins canadiens et internationaux pour collaborer à six essais pragmatiques pour tester des interventions visant à améliorer les soins d’hémodialyse. Les essais proposés sont les suivants : 1) l’essai PREFERRED (PREventing FracturEs in REnal Disease); 2) l’essai DIALEX (DIALysis with EXpanded solute removal); 3) l’essai SODIUM (Sodium fOr diaLysis oUTcome rEduction); 4) un essai portant sur les cibles de pression artérielle pour les patients sous dialyse (Finding the right blood pressure target for patients on dialysis); 5) l’essai DIURESED (DIuretic Use in patients with Residual renal function on hemodialysis); et 6) l’essai Dial-Bicarb comparant les effets d’une concentration faible ou élevée de bicarbonate dans le dialysat. Toutes les interventions ont reçu de précieux commentaires des panélistes et des participants à la conférence, qui les ont largement appuyées. Les séances de formation ont mis l’accent sur les divers éléments de conception et d’exécution des essais contrôlés, randomisés, pragmatiques intégrés aux soins courants.

Limites: La conférence pourrait être améliorée en allégeant les sujets, en accélérant le rythme des séances, en laissant plus de temps aux discussions, en augmentant les possibilités de réseautage en ligne et en améliorant les taux de réponse aux sondages. Une conférence de suivi est prévue dans quelques années; les coordinateurs viseront à mettre en œuvre ces changements.

Conclusion: La conférence Gardener’s Grove 2023 a réussi à créer un espace où patients, chercheurs et prestataires de soins se sont réunis pour soutenir l’élaboration de six nouveaux essais pragmatiques dans le contexte des soins d’hémodialyse. Depuis la conférence, plusieurs de ces essais ont obtenu du financement des IRSC, obtenu l’approbation du comité d’éthique et se préparent activement à lancer leurs interventions.

Keywords: chronic kidney disease; clinical trial; conference; hemodialysis; patient-oriented research; pragmatic trial; randomized controlled trial; registry-based randomized trial.

PubMed Disclaimer

Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

**Figure 1.**
One-word summary from attendees of the overall conference experience presented in a word cloud.

See this image and copyright information in PMC

References

1. Eknoyan G, Lameire N, Barsoum R, et al.. The burden of kidney disease: improving global outcomes. Kidney Int. 2004;66(4):1310-1314. - PubMed
1. Al-Jaishi AA, McIntyre CW, Sontrop JM, et al.. Major outcomes with personalized dialysate TEMPerature(MyTEMP): rationale and design of a pragmatic, registry-based, cluster randomized controlled trial. Can J Kidney Health Dis. 2020;7:1-18. - PMC - PubMed
1. Ferguson TW, Tangri N, Rigatto C, Komenda P. Cost-effective treatment modalities for reducing morbidity associated with chronic kidney disease. Expert Rev Pharmacoecon Outcomes Res. 2015;15(2):243-252. - PubMed
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Cultivating Innovative, Pragmatic, Randomized Controlled Registry Trials Embedded in Hemodialysis Care: Conference Proceeding From Gardener's Grove 2023

Affiliations

Cultivating Innovative, Pragmatic, Randomized Controlled Registry Trials Embedded in Hemodialysis Care: Conference Proceeding From Gardener's Grove 2023

Authors

Affiliations

Abstract
in English, French

Conflict of interest statement

Figures

References

LinkOut - more resources

Full Text Sources

Research Materials

Miscellaneous

Abstract in English, French

Conflict of interest statement

Figures

References

LinkOut - more resources

Full Text Sources

Research Materials

Miscellaneous

Abstract
in English, French