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Kidney Week

Abstract: PO1685

Effects of Veverimer on Serum Bicarbonate and Physical Function in Elderly Patients with Metabolic Acidosis in CKD

Session Information

Category: Geriatric Nephrology

  • 1100 Geriatric Nephrology

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

Use of NaHCO3 to treat acidotic pts with CKD increases daily Na load which may be particularly detrimental to elderly pts who may have hypertension and congestive heart failure.

Veverimer is a non-absorbed polymer that treats metabolic acidosis (MA) by binding and removing HCl from the GI tract. It is not an exchange resin and does not introduce unwanted cations such as Na or K. In Phase 3 randomized, blinded, placebo-controlled trials, veverimer significantly increased serum bicarbonate and improved subjective and objective measures of physical function in pts with MA in CKD (Wesson et al. Lancet, 2019). Here we report data from pts aged >65 yrs from these studies.

Methods

Patients were treated for up to 1 yr with veverimer or placebo with frequent determinations of blood bicarbonate. Physical function was assessed at Baseline and Weeks 12, 40, and 52 using the KDQOL-PFD which quantifies limitations on daily activities and by performance on the repeated chair stand (RCS) test.

Results

Of the 217 pts randomized, 113 (52%) were >65 yrs (mean 72 yrs). Select comorbidities included HTN (98%), diabetes (70%), and CHF (40%). At Baseline, the mean eGFR was 30.7 mL/min/1.73m2 and the mean serum bicarbonate was 17.2 mEq/L. In this elderly cohort, more pts receiving veverimer met the primary study endpoint, had a significant increase in serum bicarbonate, and improved both KDQOL-PFD scores and RCS time (Table) compared with placebo. These effects of veverimer exceeded the minimal clinically important difference for both the KDQOL-PFD (+3 to +5 points) and RCS (-1.7 seconds). Safety was similar in both treatment groups.

Conclusion

In older adults with CKD, treatment with veverimer significantly increased serum bicarbonate levels and improved how pts felt and functioned. The safety of veverimer was not different from placebo.

Efficacy EndpointsPlacebo
(N = 48)
Veverimer
(N = 65)
Primary Endpoint: proportion increasing serum bicarbonate by > 4 mEq/L or achieving normalization at Week 1225%76%
P<0.0001
Change from baseline in Serum Bicarbonate
(LS mean, mEq/L) at Week 12
+2.1+5.4
P< 0.0001
Patient-Reported Physical Function
(Change from baseline in mean [SD] KDQOL-PFD total score at Week 52)*
-0.13 (20.84)+10.95 (21.57)
P = 0.003
Objective Measurement of Physical Function
(Change from baseline in mean (SD) repeated chair stand time at Week 52, seconds)*
-2.46 (13.77)-2.59 (7.55)
P = 0.003
 

P-values are vs. placebo; An ANCOVA rank-based method was used for physical function endpoints *Based on evaluable patients enrolled in controlled extension study (placebo, n=38; veverimer, n=58)

Funding

  • Commercial Support