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Kidney Week

Abstract: TH-PO356

Baseline Characteristics of Early Enrollees in TRACK, a Prospective Study of Hyperkalemia Management Decision-Making

Session Information

Category: Fluid, Electrolytes, and Acid-Base Disorders

  • 1102 Fluid, Electrolyte, and Acid-Base Disorders: Clinical

Authors

  • Hsia, Judith, University of Colorado, Denver, Colorado, United States
  • Shivappa, Nitin, Biopharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, United States
  • Bakhai, Ameet, Royal Free London NHS Foundation Trust, London, United Kingdom
  • Bover, Jordi, Hospital Universitari Germans Trias i Pujol, Badalona, Catalunya, Spain
  • Butler, Javed, Baylor Scott and White Research Institute, Dallas, Texas, United States
  • Ferraro, Pietro Manuel, Universita Cattolica del Sacro Cuore, Milano, Lombardia, Italy
  • Fried, Linda F., University of Pittsburgh, Pittsburgh, Pennsylvania, United States
  • Schneider, Markus P., University of Erlangen-Nürnberg, Erlangen, Bavaria, Germany
  • Tangri, Navdeep, University of Manitoba, Winnipeg, Manitoba, Canada
  • Winkelmayer, Wolfgang C., Baylor College of Medicine, Houston, Texas, United States
  • Bishop, Meredith S., Biopharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, United States
  • Chen, Hungta (tony), Biopharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, United States
  • Järbrink, Krister, Biopharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden
  • Sundin, Anna-Karin, Biopharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden
  • Bonaca, Marc P., University of Colorado, Denver, Colorado, United States
Background

The TRACK study is a prospective, observational, implementation science study designed to address the evidence gap regarding healthcare provider decision-making and management of patients with hyperkalemia (HK).

Methods

The study will enroll 1250 patients with HK in the US and Europe and record management decisions, treatment objectives and outcomes, HK recurrence and attainment of target renin-angiotensin-aldosterone system inhibitor (RAASi) dose during 12 months following an index episode of HK. The planned sample size provides a margin of error <3% to estimate endpoints of interest such as attainment of target doses of RAASi therapies at month 12. Eligible participants are adults with serum K+ >5.0 mmol/L collected during standard of care within 14 days prior to informed consent. Baseline characteristics of early enrollees are presented descriptively.

Results

Baseline characteristics and initial HK management approach are shown for the first 62 enrollees. Chronic kidney disease (CKD) and/or heart failure was present in 90%. Mineralocorticoid receptor antagonist use was reported by 7% and other RAASi by 53%. RAASi downtitration and discontinuation during the qualifying HK episode was reported for (18%). Median K+ was 5.4 mmol/L (IQR 5.2-5.6); eGFR 26 mL/min/1.73m2 (IQR 15, 35). The most common initial management strategies for the index episode of HK, apart from monitoring serum K+, were prescription of a low K+ diet and use of K+ binders (Table). We anticipate enrolling approximately half of the planned 1250 participants for presentation at Kidney Week.

Conclusion

TRACK will characterize contemporary provider decision-making in patients with HK and its impact on HK recurrence across a broad range of patient types in a variety of practice settings in the US and Europe.

Funding

  • Commercial Support – AstraZeneca