Effects of Veverimer on Serum Bicarbonate and Physical Function in Women with CKD: A Subgroup Analysis from a Randomized Controlled Trial
Bibliographic record
Abstract
Background: More women than men have CKD. However, women have been under-represented in clinical trials. Veverimer is an orally administered, non-absorbed polymer that treats metabolic acidosis by binding and removing HCl from the GI tract. In Phase 3 randomized, double-blind, placebo-controlled trials, veverimer significantly increased serum bicarbonate and improved physical function in acidotic patients with CKD (Wesson et al. Lancet, 2019). Here we analyzed efficacy and safety among the women in these studies of up to one year. Methods: Physical function was assessed using the Kidney Disease and Quality of Life Physical Function Domain (KDQOL-PFD) which quantifies limitations on daily activities and by performance on the repeated chair stand (RCS) test. Results: Of the 217 pts randomized, 83 (32%) were women, of whom 81% were post-menopausal (≥55 yrs). Select comorbidities included hypertension (95%), diabetes (64%), and congestive heart failure (30%). At Baseline, mean eGFR in women was 28.4 mL/min/1.73m2 and mean serum bicarbonate was 17.3 mEq/L. More women 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. The effects of veverimer exceeded the minimal clinically important difference for both KDQOL-PFD (+3 to +5 points) and RCS (-1.7 seconds). Rates of serious, non-serious and GI adverse events were similar in the groups; none required treatment discontinuation. Conclusions: Given their lower bone and muscle mass, women with CKD may be particularly vulnerable to the adverse effects of metabolic acidosis. We found that in women with CKD and metabolic acidosis, treatment with veverimer significantly improved how women felt and functioned. The safety of veverimer was similar to placebo. Funding: Commercial Support - Tricida, Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.012 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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 source (direct Gemma or distilled Codex), 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".