Evidence map›Paper›PMID 28741050›Full record

Trial reportClinical and experimental nephrology2018

Risk factors for progression of chronic kidney disease in the EPPIC trials and the effect of AST-120.

Gerald Schulman, Tomas Berl, Gerald J Beck, Giuseppe Remuzzi, Eberhard Ritz, Miho Shimizu, Mami Kikuchi, Yuko Shobu

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
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 2 registered trials, which are not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
3.5field-weighted citation impact, top 7% 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.

NCT00500682 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease

TypeinterventionalSponsorTanabe Pharma CorporationRan2007 to 2011Enrolled1,020ConditionsChronic Kidney DiseaseArmsPlacebo, AST-120
NCT00501046 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease Including Assessment of Quality of Life

TypeinterventionalSponsorTanabe Pharma CorporationRan2007 to 2011Enrolled1,015ConditionsChronic Kidney DiseaseArmsPlacebo, AST-120
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 34 citations in OpenAlex.

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  19. Glomerular Hematuria: Cause or Consequence of Renal Inflammation?International journal of molecular sciences · 2019
    Review
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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

8 authors at 7 institutions in 4 countries.

Gerald SchulmanVanderbilt University School of Medicine, Nashville, TN, USA.
Tomas BerlUniversity of Colorado Health Sciences Center, Denver, CO, USA.
Gerald J BeckCleveland Clinic Foundation, Cleveland, OH, USA.
Giuseppe RemuzziUnit of Nephrology and Dialysis, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
Eberhard RitzUniversity of Heidelberg, Heidelberg, Germany.
Miho ShimizuMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Mami KikuchiKureha Corporation, 3-26-2, Hyakunin-cho, Shinjuku-ku, Tokyo, 169-8503, Japan. mami-k@kureha.co.jp.
Yuko ShobuKureha Corporation, 3-26-2, Hyakunin-cho, Shinjuku-ku, Tokyo, 169-8503, Japan.
Kureha (Japan) · JPCleveland Clinic · USHeidelberg University · DEMitsubishi Tanabe Pharma CorporationOspedale Papa Giovanni XXIII · ITUniversity of Colorado Health · USVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTwo randomized, double-blind, placebo-controlled trials (EPPIC-1 and EPPIC-2) investigated the efficacy and safety of AST-120, an oral spherical carbon adsorbent, in adults with chronic kidney disease (CKD). While the benefit of adding AST-120 to standard therapy was not supported by these trials, we performed a post hoc analysis to focus on CKD progression and to determine the risk factors for the primary endpoint in the EPPIC trial population.

methodsIn the EPPIC trials, patients were randomly assigned 1:1 to treatment with AST-120 or placebo. The primary endpoint was a composite of dialysis initiation, kidney transplantation, or doubling of serum creatinine. The EPPIC trial pooled population was evaluated with the same statistical methods used for analysis of the primary and secondary efficacy endpoints. The trials were registered on ClinicalTrials.gov (NCT00500682 [EPPIC-1] and NCT00501046 [EPPIC-2]).

resultsAn analysis of the placebo population suggested baseline urinary protein to urinary creatinine ratio (UP/UCr) ≥1.0 and hematuria were independent risk factors for event occurrence and eGFR lowering. Analysis of the high risk patients revealed a difference in the primary endpoint occurrence between treatment groups, if angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers were administered (hazard ratio 0.74, 95% confidence interval 0.56-0.96). Also, the eGFR changes from baseline in the AST-120 group were smaller than that in the placebo group (P = 0.035).

conclusionsCKD progression may have an association with baseline UP/UCr and hematuria. Treatment with AST-120 may delay the time to the primary endpoint in patients with progressive CKD receiving standard therapy, thus warranting further investigation.

Indexed as

AdultAgedBiomarkersCarbonCreatinineDisease ProgressionDouble-Blind MethodFemaleGlomerular Filtration RateHematuriaHumansKidneyKidney Failure, ChronicKidney TransplantationMaleMiddle AgedAST 120BiomarkersCarbonCreatinineOxidesAST-120CKDCKD progressionClinical trialSpherical carbon adsorbentUremic toxins

Identifiers

PMID28741050
PMCPMC5838144
OpenAlexW2738843044

What OpenQuestion holds

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LicenceCC BY
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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.