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Abstract: PO1033

Effects of Veverimer on Serum Bicarbonate and Physical Function in Patients with Diabetes and CKD: Subgroup Analysis from a Randomized Trial

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Wesson, Donald E., Baylor Scott & White Health and Wellness Center, Dallas, Texas, United States
  • Mathur, Vandana S., MathurConsulting, Woodside, California, United States
  • Tangri, Navdeep, University of Manitoba, Winnipeg, Manitoba, Canada
  • Stasiv, Yuri, Tricida, Inc., South San Francisco, California, United States
  • Parsell, Dawn, Tricida, Inc., South San Francisco, California, United States
  • Li, Elizabeth, PharmaStat LLC, Fremont, California, United States
  • Klaerner, Gerrit, Tricida, Inc., South San Francisco, California, United States
  • Bushinsky, David A., University of Rochester Medical Center, Rochester, New York, United States
Background

Metabolic acidosis (MA) is a complication of CKD and has deleterious effects on kidney function, bone (demineralization), and muscle (protein catabolism). Patients (pts) with diabetes and CKD are prone to functional limitations that adversely affect their quality of life. Veverimer, an investigational non-absorbed polymer that binds gastrointestinal hydrochloric acid, is being developed to treat MA in CKD.

Methods

TRCA-301E is a multicenter, Phase 3, randomized, blinded, placebo-controlled trial in 196 pts with CKD (eGFR 20-40 ml/min/1.73 m2) and MA (serum bicarbonate 12-20 mEq/L) who were treated for up to 1 yr with veverimer or placebo, with dose titration targeted to achieve a normal serum bicarbonate.

Results

Compared with placebo, veverimer significantly increased serum bicarbonate and significantly improved physical function as reported on the Kidney Disease and Quality of Life-Physical Function Domain (KDQOL-PFD) and the 5-times repeated chair stand test (RCS) with a safety profile that was similar to placebo (Wesson, The Lancet 2019). In the subgroup with diabetes (n=70, veverimer; n=57, placebo), mean age was 63years, mean baseline eGFR was 28.5 mL/min/1.73 m2, and mean serum bicarbonate was 17.3 mEq/L; 10% were on background oral alkali. In the veverimer group, at Week 52, mean serum bicarbonate increased by 4.39 mEq/L (P<0.05 vs. placebo) and significantly more pts had a ≥4mEq/L increase or normalization of serum bicarbonate (64% v 38%, P< 0.01). Pt-reported limitations of physical function (KDQOL-PFD) (e.g. walking several blocks, climbing a flight of stairs) significantly improved in the veverimer group (+12.5 v +0.3, P<0.001) as did objective physical performance on the RCS at Week 52 (P<0.0001). There was no significant effect of the presence or absence of diabetes on the effect of veverimer on improvement in either measure of physical function (rank-based ANCOVA, P≥0.6).

Conclusion

Few interventions for CKD have improved QOL or physical functioning. Our study demonstrates that veverimer is an effective treatment for diabetic pts with MA in CKD. Treatment with veverimer significantly improved how these pts felt and functioned.

Funding

  • Commercial Support –