Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be
randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be
progression of renal disease, defined by time to first occurrence of any event in the
composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease
(ESRD), and renal death. The study will terminate when the independent blinded Clinical
Endpoint Adjudication Committee has positively adjudicated the targeted number of primary
efficacy endpoint events. The average duration of follow-up is anticipated to be 3.5 years.

Inclusion Criteria:

- Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2.

- Serum bicarbonate 12 - 20 mEq/L.

- On maximum tolerated dose of ACE inhibitor and/or ARB.

Exclusion Criteria:

- Acute metabolic acidosis.

- Anticipated dialysis or kidney transplant within 6 months.

- Recent acute kidney injury.