1. Randomized, Controlled Trial of TRC101 to Increase Serum Bicarbonate in Patients with CKD
- Author
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Claire Lockey, Robert J. Alpern, Yuri Stasiv, Jerry M. Buysse, Thomas H. Hostetter, Angela Lee, David A. Bushinsky, Elizabeth Li, Gerrit Klaerner, Sarah McNulty, Dawn Parsell, and Vandana Mathur
- Subjects
Adult ,Male ,medicine.medical_specialty ,Georgia ,Time Factors ,Polymers ,Epidemiology ,030232 urology & nephrology ,030204 cardiovascular system & hematology ,Kidney ,Critical Care and Intensive Care Medicine ,Placebo ,Gastroenterology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Randomized controlled trial ,law ,Diabetes mellitus ,Internal medicine ,medicine ,Humans ,Dosing ,Renal Insufficiency, Chronic ,Bulgaria ,Adverse effect ,Aged ,Chelating Agents ,Acidosis ,Acid-Base Equilibrium ,Transplantation ,business.industry ,Metabolic acidosis ,Middle Aged ,medicine.disease ,United States ,Bicarbonates ,Treatment Outcome ,Nephrology ,Heart failure ,Female ,Erratum ,medicine.symptom ,business ,Biomarkers ,Glomerular Filtration Rate - Abstract
Background and objectives Metabolic acidosis is common in patients with CKD and has significant adverse effects on kidney, muscle, and bone. We tested the efficacy and safety of TRC101, a novel, sodium-free, nonabsorbed hydrochloric acid binder, to increase serum bicarbonate in patients with CKD and metabolic acidosis. Design, setting, participants, & measurements One hundred thirty-five patients were enrolled in this randomized, double-blind, placebo-controlled, multicenter, in-unit study (designated the TRCA-101 Study). Patients had a mean baseline eGFR of 35 ml/min per 1.73 m 2 , a mean baseline serum bicarbonate of 17.7 mEq/L, and comorbidities, including hypertension (93%), diabetes (70%), and heart failure (21%). Patients ate a controlled diet and were treated for 14 days with placebo or one of four TRC101 dosing regimens (1.5, 3, or 4.5 g twice daily or 6 g once daily). After treatment, patients were discharged and followed for 7–14 days. Results All TRC101 treatment groups had a mean within-group increase in serum bicarbonate of ≥1.3 mEq/L ( P P Conclusions TRC101 safely and significantly increased the level of serum bicarbonate in patients with metabolic acidosis and CKD.
- Published
- 2017