Evidence map›Paper›PMID 35216581›Full record

Trial reportBMC nephrology2022

Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial.

Vandana S Mathur, Donald E Wesson, Navdeep Tangri, Elizabeth Li, David A Bushinsky

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03390842 (A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03390842 phase3completednot on this map

A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

TypeinterventionalSponsorTricida, Inc.Ran2017 to 2019Enrolled196ConditionsMetabolic AcidosisArmsTRC101, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Vandana S MathurMathurConsulting LLC, 25 Upenuf Road, Suite 100, Woodside, CA, 94062-2633, USA. md@mathurconsulting.com.
Donald E WessonTexas A&M Health Sciences Center College of Medicine, Dallas, TX, USA.
Navdeep TangriUniversity of Manitoba, Winnipeg, MB, Canada.
Elizabeth LiPharmastat LLC, Fremont, CA, USA.
David A BushinskyUniversity of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
SangStat Medical Corporation · USTexas A&M Health Science Center · USUniversity of Manitoba · CAUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlobally, the prevalence of chronic kidney disease (CKD) is higher in women than in men; however, women have been historically under-represented in nephrology clinical trials. Metabolic acidosis increases risk of progressive loss of kidney function, causes bone demineralization and muscle protein catabolism, and may be more consequential in women given their lower bone and muscle mass. Veverimer, an investigational, non-absorbed polymer that binds and removes gastrointestinal hydrochloric acid, is being developed as treatment for metabolic acidosis.

methodsThis was a Phase 3, multicenter, randomised, blinded, placebo-controlled trial in 196 patients with CKD (eGFR: 20-40 mL/min/1.73 m

resultsAt week 52, women treated with veverimer had a greater increase in mean (± standard error) serum bicarbonate than the placebo group (5.4 [0.5] vs. 2.2 [0.6] mmol/L; P < 0.0001). Physical Function reported by patients on the Kidney Disease and Quality of Life - Physical Function Domain, a measure that includes items related to walking, stair climbing, carrying groceries and other activities improved significantly in women randomized to veverimer vs placebo (+ 13.2 vs. -5.2, respectively, P < 0.0031). Objectively measured performance time on the repeated chair stand test also improved significantly in the veverimer group vs. placebo (P = 0.0002).

conclusionsVeverimer was effective in treating metabolic acidosis in women with CKD, and significantly improved how they felt and functioned.

trial registrationClinicalTrials.gov Identifier: NCT03390842 . Registered on January 4, 2018.

Indexed as

AcidosisAgedBicarbonatesDouble-Blind MethodFemaleHumansMiddle AgedPolymersRenal Insufficiency, ChronicBicarbonatesPolymersveverimerChronic kidney diseaseDisparityMetabolic acidosisPhysical functionSerum bicarbonateSexVeverimerWomen

Identifiers

PMID35216581
PMCPMC8881824
OpenAlexW4214629836

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.