This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
217
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).
Time frame: Baseline to Week 12
Change From Baseline to End of Treatment in Serum Bicarbonate
Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
Time frame: Baseline to Week 12
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Investigative Site 55
Phoenix, Arizona, United States
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Chula Vista, California, United States
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Los Angeles, California, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Hollywood, Florida, United States
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Lauderdale Lakes, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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