Evidence map›Paper›PMID 36811175›Full record

ArticleClinical pharmacokinetics2023

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment.

Mikkel Askjær Agersnap, Kim Sonne, Kim Mark Knudsen, Wladyslaw Sulowicz

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04178447 (An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.9field-weighted citation impact, top 15% 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.

NCT04178447 phase1completednot on this map

An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function

TypeinterventionalSponsorZealand PharmaRan2019 to 2020Enrolled16ConditionsRenal ImpairmentArmsGlepaglutide
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Mikkel Askjær AgersnapZealand Pharma A/S, Sydmarken 11, 2860, Søborg, Denmark. miagersnap@gmail.com.ORCID http://orcid.org/0000-0002-5827-5870
Kim SonneZealand Pharma A/S, Sydmarken 11, 2860, Søborg, Denmark.
Kim Mark KnudsenZealand Pharma A/S, Sydmarken 11, 2860, Søborg, Denmark.
Wladyslaw SulowiczSCM Spółka z o.o., Krakow, Poland.
Zealand Pharma (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlepaglutide is a novel, ready-to-use, long-acting, glucagon-like peptide-2 (GLP-2) analog intended for the treatment of patients with short bowel syndrome (SBS). This study investigated the impact of renal function on the pharmacokinetics and safety of glepaglutide.

methodsIn this 3-site, non-randomized, open-label study, 16 subjects were enrolled: 4 with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m

resultsThere was no clinically relevant difference between subjects with severe renal impairment/ESRD and normal renal function with respect to total exposure (AUC

conclusionsNo difference in glepaglutide pharmacokinetics was seen between renal impaired and normal subjects. Based on this trial, dose adjustment appears not to be warranted in SBS patients with renal impairment.

trial registrationThe trial is registered at http://www. CLINICALTRIALS: gov (NCT04178447) and has the EudraCT number: 2019-001466-15.

Indexed as

Kidney Failure, ChronicRenal InsufficiencyArea Under CurveHumansKidneyRenal Dialysis

Identifiers

PMID36811175
PMCPMC10085944
OpenAlexW4321437501

What OpenQuestion 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 OpenQuestion graph.