Effects of Veverimer on Serum Bicarbonate and Physical Function in Elderly Patients with Metabolic Acidosis in CKD
Bibliographic record
Abstract
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. Conclusions: 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. Funding: Commercial Support - Tricida, Inc.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)
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".