Takeaway
- 52-week data confirm veverimer safety and efficacy for correcting metabolic acidosis associated with chronic kidney disease (CKD).
- Physical function measures also improved.
Why this matters
- The investigational agent binds and removes hydrochloric acid from the gastrointestinal lumen rather than neutralizing accumulated acid.
- The manufacturer plans to seek FDA accelerated approval.
Study design
- 40-week extension study followed a 12-week randomized, multicenter phase 3 trial in which patients with nondialysis-dependent CKD continued veverimer (n=114) or placebo (n=82).
- Funding: Tricida.
Key results
- Vs placebo, veverimer was associated with fewer:
- Early discontinuations (3% vs 10%).
- Serious adverse events (2% vs 5%).
- Renal system adverse events (8% vs 15%).
- At week 52, more veverimer-treated patients:
- Achieved the composite endpoint (63% vs 38%; P=.0015) of ≥4 mmol/L increase or normalization of serum bicarbonate concentration; and
- Higher normalization rate (57% vs 27%; P=.0001).
- Higher bicarbonate concentrations seen with veverimer at all timepoints from week 1 (P≤.0005).
- Veverimer improved patient-reported physical function, based on a 12.1-point improvement vs placebo on the Kidney Disease and Quality of Life Short-Form-36, question 3 (P<.0001).
- Time to perform the repeat chair stand test showed greater improvement with veverimer vs placebo (decreased 4.3 vs 1.4 seconds; P<.0001).
Limitations
- Ethnic homogeneity (>95% white).
References
References
