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Kidney Week

Abstract: INFO16

Understanding the Long-Term Impact of Metabolic Acidosis in Chronic Kidney Disease: Design of the ULTIMA-CKD Patient Registry

Session Information

Category: Fluid, Electrolyte, and Acid-Base Disorders

  • No subcategory defined

Authors

  • Mathur, Vandana S., MathurConsulting, Woodside, California, United States
  • Parsell, Dawn, Tricida, Inc., South San Francisco, California, United States
  • Li, Elizabeth, PharmaStat LLC, Newark, California, United States
  • Sullivan, Dawn, Tricida, Inc., South San Francisco, California, United States
  • Klaerner, Gerrit, Tricida, Inc., South San Francisco, California, United States
Description

Background:
Approximately 15% of US adults have chronic kidney disease (CKD) and >30% of those with Stage 4 and 5 non-dialysis-dependent CKD have metabolic acidosis. Although metabolic acidosis is a modifiable risk factor for CKD progression, and the KDIGO guidelines recommend maintaining total blood CO2 >22 mEq/L (KDIGO. Kidney Int. 2013), most patients remain untreated. In a recent study, only 2.7% of patients with total CO2 <22 mEq/L were receiving oral alkali (Dobre. Am J Kidney Dis. 2013). Treatment practices and the natural history of disease in patients with CKD and metabolic acidosis are not well characterized. This study will also collect information on hospitalizations, including those for COVID-19, as well as information on COVID-19 infection and antibody status.

Methods:
ULTIMA-CKD is a prospective, observational, longitudinal cohort study of patients with metabolic acidosis (2 consecutive serum bicarbonate values <22 mEq/L) and non-dialysis CKD (2 estimated glomerular filtration rates <60 mL/min/1.73 m2). The objectives are to describe clinical characteristics and management of this population over time; to identify characteristics associated with better/worse health outcomes; and to assist nephrologists in identifying trends within their practices.

Results:
Patients who have provided informed consent and are being regularly seen in one of ≈100 US nephrology practices are being followed for up to 6 years. Medical records from regularly scheduled clinic visits are being extracted, anonymized, and entered into the registry database by a 3rd party. No study visits or procedures are required. Data collected are those typically available from nephrology clinic visits (i.e., medical history, medications, blood pressure, laboratory measurements) as well as outcome events (e.g., dialysis, death, hospitalizations, and urgent clinic visits). The streamlined procedures allow nephrology clinics with or without research infrastructure to participate. Site initiation visits and patient consent can be done virtually. The study is ongoing, and we are actively recruiting sites.

Conclusions:
The results of the ULTIMA-CKD registry will provide real-world data on treatment practices and the natural history of metabolic acidosis in CKD.

Funding

  • Tricida, Inc.