Evidence mapPaperPMID 29159529Full record

Trial reportClinical and experimental nephrology2018

Plasma p-cresol lowering effect of sevelamer in non-dialysis CKD patients: evidence from a randomized controlled trial.

Eleonora Riccio, Massimo Sabbatini, Dario Bruzzese, Lucia Grumetto, Cristina Marchetiello, Maria Amicone, Michele Andreucci, Bruna Guida, Davide Passaretti, Giacomo Russo and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical and experimental nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02199444 (Effect of Sevelamer on P-cresol Levels in CKD), which is not on this map. Cited by 18 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 5 pooled it
2.0field-weighted citation impact, top 13% 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.

NCT02199444 phase3unknown statusnot on this map

Effect of Sevelamer on P-cresol Levels in CKD

TypeinterventionalSponsorFederico II UniversityRan2014Enrolled200ConditionsChronic Kidney Disease Stage 3-5ArmsSevelamer, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 5 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
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  17. Cardiovascular risk factors in children on dialysis: an update.Pediatric nephrology (Berlin, Germany) · 2020
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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

11 authors at 3 institutions in 1 country.

Eleonora RiccioDepartment of Nephrology, Second University of Naples, Naples, Italy. elyriccio@libero.it.
Massimo SabbatiniChair of Nephrology, Department of Public Health, Federico II University of Naples, Naples, Italy.
Dario BruzzeseChair of Statistics, Department of Public Health, Federico II University of Naples, Naples, Italy.
Lucia GrumettoDepartment of Pharmacy, School of Medicine and Surgery, Federico II University of Naples, Naples, Italy.
Cristina MarchetielloChair of Nephrology, Department of Public Health, Federico II University of Naples, Naples, Italy.
Maria AmiconeChair of Nephrology, Department of Public Health, Federico II University of Naples, Naples, Italy.
Michele AndreucciUnit of Nephrology, Department of Health Sciences, "Magna Graecia" University, Catanzaro, Italy.
Bruna GuidaDivision of Physiology, Department of Clinical Medicine and Surgery, Federico II University of Naples, Naples, Italy.
Davide PassarettiDepartment of Economics and Law, University of Cassino and Southern Lazio, Cassino, Italy.
Giacomo RussoDepartment of Pharmacy, School of Medicine and Surgery, Federico II University of Naples, Naples, Italy.
Antonio PisaniChair of Nephrology, Department of Public Health, Federico II University of Naples, Naples, Italy.
University of Naples Federico II · ITMagna Graecia University · ITUniversità degli studi di Cassino e del Lazio Meridionale · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe accumulation of p-cresol, a metabolic product of aromatic amino acids generated by intestinal microbiome, increases the cardiovascular risk in chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer (SEV) sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of SEV on p-cresol levels in non-dialysis CKD patients.

methodsThis was a single-blind, randomized placebo-controlled trial (Registration number NCT02199444) carried on 69 CKD patients (stage 3-5, not on dialysis), randomly assigned (1:1) to receive either SEV or placebo for 3 months. Total p-cresol serum levels were evaluated at baseline (T0), and 1 (T1) and 3 months (T3) after treatment start. The primary end-point was to evaluate the effect of SEV on p-cresol levels.

resultsCompared to baseline (T0, 7.4 ± 2.7 mg/mL), p-cresol mean concentration was significantly reduced in SEV patients after one (- 2.06 mg/mL, 95% CI - 2.62 to - 1.50 mg/mL; p < 0.001) and 3 months of treatment (- 3.97 mg/mL, 95% CI - 4.53 to - 3.41 mg/mL; p < 0.001); no change of plasma p-cresol concentration was recorded in placebo-treated patients. Moreover, P and LDL values were reduced after 3 months of treatment by SEV but not placebo.

conclusionsIn conclusion, our study represents the first evidence that SEV is effective in reducing p-cresol levels in CKD patients in conservative treatment, and confirms its beneficial effects on inflammation and lipid pattern.

Indexed as

AdultAgedChelating AgentsCresolsFemaleHumansMaleMiddle AgedRenal Insufficiency, ChronicSevelamer4-cresolChelating AgentsCresolsSevelamerCardiovascular riskChronic kidney diseasep-CresolSevelamer

Identifiers

PMID29159529
OpenAlexW2768439266

What Socratic holds

Textmetadata
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 Socratic graph.