Evidence map›Paper›PMID 30676701›Full record

ArticleClinical pharmacology in drug development2019

Influence of Renal Function on Evolocumab Exposure, Pharmacodynamics, and Safety.

Edward Lee, John P Gibbs, Maurice G Emery, Geoffrey Block, Scott M Wasserman, Lisa Hamilton, Sreeneeranj Kasichayanula, Patrick Hanafin, Ransi Somaratne, Ogo Egbuna

Registry-linked trialAbstract readClinical Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical pharmacology in drug development, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02275156. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT02275156 phase1completed

Phase 1, Open-label, Single-dose Study of Evolocumab (AMG 145) Administered Subcutaneously to Subjects With Normal Renal Function or Severe Renal Impairment or End Stage Renal Disease Receiving Hemodialysis

Ran2014Enrolled18Registered outcomes7Posted comparisons0ConditionsHyperlipidemia, Mixed DyslipidemiaArmsEvolocumab
PMID 29353350other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
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

10 authors.

Edward LeeAmgen Inc., Thousand Oaks, CA, USA.
John P GibbsAmgen Inc., Thousand Oaks, CA, USA.
Maurice G EmeryAmgen Inc., Thousand Oaks, CA, USA.
Geoffrey BlockDenver Nephrology Research Division, Denver, CO, USA.
Scott M WassermanAmgen Inc., Thousand Oaks, CA, USA.
Lisa HamiltonAmgen Ltd., Uxbridge, United Kingdom.
Sreeneeranj KasichayanulaAmgen Inc., Thousand Oaks, CA, USA.
Patrick HanafinAmgen Inc., Thousand Oaks, CA, USA.
Ransi SomaratneAmgen Inc., Thousand Oaks, CA, USA.
Ogo EgbunaAmgen Inc., Thousand Oaks, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluated the pharmacokinetics, pharmacodynamics, and safety of evolocumab, a fully human monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), in an open-label, parallel-design study in participants with normal renal function (n = 6), severe renal impairment (RI; n = 6), or end-stage renal disease (ESRD) receiving hemodialysis (n = 6) who received a single 140-mg dose of evolocumab. The effects of evolocumab treatment on low-density lipoprotein cholesterol (LDL-C) lowering and unbound PCSK9 concentrations were similar in the normal renal function group and the renally impaired groups. Geometric mean C

Indexed as

Antibodies, Monoclonal, HumanizedAnticholesteremic AgentsArea Under CurveCholesterol, LDLCreatinineFemaleGlomerular Filtration RateHumansInjections, SubcutaneousKidneyKidney Failure, ChronicMaleMiddle AgedPCSK9 InhibitorsProprotein Convertase 9Protein BindingAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLCreatinineevolocumabPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9evolocumabhuman monoclonal antibodyLDL-CPCSK9pharmacokinetics and pharmacodynamicsrenal impairment

Identifiers

PMID30676701
PMCPMC6590207

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.