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.