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Randomized, Controlled Trial of TRC101 to Increase Serum Bicarbonate in Patients with CKD
- Source :
- Clinical Journal of the American Society of Nephrology. 13:26-35
- Publication Year :
- 2017
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2017.
-
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.
- 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
Subjects
Details
- ISSN :
- 1555905X and 15559041
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- Clinical Journal of the American Society of Nephrology
- Accession number :
- edsair.doi.dedup.....8f0fabeaf8c3ecf8fb6bd29daf46477a