Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

Key Inclusion Criteria:

• Blood bicarbonate level of 12 to 20 mEq/L.
• Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
• Stable kidney function defined as <=20% variability in eGFR during screening period.

Key Exclusion Criteria:

• Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
• Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
• Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
• Heart or kidney transplant.
• Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
• Change in doses to alkali therapy in the 4 weeks prior to screening.
• History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
• Serum calcium <= 8.0 mg/dL at screening.
• Planned initiation of renal replacement therapy within 12 weeks following randomization.
• Use of polymeric binder drugs within 14 days prior to screening.