Tricida announced findings from its Phase 3 TRCA-301 trial evaluating TRC101 in chronic kidney disease (CKD) patients with metabolic acidosis. This first-in-class candidate is a unique non-absorbed polymer drug designed to bind HCl in the gastrointestinal tract, removing it from the body with high capacity and specificity.
TRC101 was evaluated in a multicenter, double-blind, randomized, placebo-controlled trial (N=217) that included patients with stage 3b or 4 CKD with baseline blood bicarbonate levels of 12 to 20mEq/L. Patients were randomized to either TRC101 or placebo once daily.
After 12 weeks, 59.2% of patients treated with the study drug saw an increased blood bicarbonate of ≥4mEq/L or achieved a level in the normal range (22 to 29mEq/L) vs 22.5% of patients in the placebo group (primary endpoint; P <.0001). Also, patients treated with TRC101 demonstrated a mean change in blood bicarbonate from baseline to week 12 of +4.49mEq/L vs +1.66mEq/L in the placebo group (secondary endpoint; P <.0001).
Two other exploratory endpoints — quality of life and improvement in muscle function — were also evaluated in the trial. Topline data showed a statistically significant positive improvement in the physical functioning KDQOL-SF survey among TRC101-treated patients vs the placebo group after 12 weeks (P =.0122). Patients treated with TRC101 also showed a positive difference in the repeated chair stand test vs placebo (P =.0630).
For more information call (415) 429-7800 or visit Tricida.com.