Conditions: Acidosis
Keywords: metabolic acidosis serum bicarbonate kidney disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD).

The maximum study duration per subject was anticipated to be up to 42 days.

Detailed description:

Arms:
arm 1: Administered twice daily (BID) for 14 days arm 2: Administered twice daily (BID) for 14 days arm 3: Administered twice daily (BID) for 14 days arm 4: Administered twice daily (BID) for 14 days arm 5: Administered once daily (QD) for 14 days arm 6: Administered once daily (QD) for 14 days

Interventions: intervention 1: Placebo intervention 2: TRC101
Intervention descriptions: intervention 1: oral suspension intervention 2: oral suspension

Protocol document: