Pharmacokinetics of teduglutide in subjects with renal impairment.

Nave R, Halabi A, Herzog R, Schaffer P, Diefenbach J, Krause S, Berghöfer P, Lahu G, Hartmann M

European journal of clinical pharmacology28 Nov 2012Cited by 14 (Europe PMC)

PMID23187965DOI10.1007/s00228-012-1455-7PepBankPUB-23187965

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialPharmacokinetics
In subjects with end-stage renal disease, teduglutide AUCinf was approximately 2.59-fold higher than in healthy subjects.
In plain wordsIn subjects with end-stage renal disease, teduglutide exposure was approximately 2.59-fold higher than in healthy subjects.
Peptide
Teduglutide
Outcome
IncreaseAUCinf in end-stage renal disease
Study
n: not reported in source
Comparator
Healthy subjects with normal renal function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 mg single dose · subcutaneousAs given in this study (human).
Measurements
AUCinf ratio vs healthy subjects
≈ 2.59 fold
end-stage renal disease vs healthy subjects
Source sentences
Summary
Area under the concentration versus time curve extrapolated to infinity (AUCinf) and maximum plasma concentration (Cmax) of teduglutide in subjects with end-stage renal disease were approximately 2.59- and 2.08-fold higher, respectively, than those of healthy subjects.
4 context sentences(design, population, supporting numbers)
Summary · context
Teduglutide plasma concentrations were measured using a validated liquid chromatography method with tandem mass spectrometric detection, and the primary pharmacokinetic variables (AUCinf and Cmax) were calculated.
Summary · context
This was an open-label study with six parallel groups (6 subjects each).
Summary · context
Three groups with renal impairment (moderate, severe and end-stage renal disease) were compared to healthy subjects with normal renal function, which were matched to the renal-impaired subjects with respect to demographics.
Summary · context
A single dose of 10 mg teduglutide was subcutaneously administered to each subject.
Report a problemFND-2318796501
02HumanNon-randomized trialPharmacokinetics
In subjects with end-stage renal disease, teduglutide Cmax was approximately 2.08-fold higher than in healthy subjects.
In plain wordsIn subjects with end-stage renal disease, peak teduglutide levels were approximately 2.08-fold higher than in healthy subjects.
Peptide
Teduglutide
Outcome
IncreaseCmax in end-stage renal disease
Study
n: not reported in source
Comparator
Healthy subjects with normal renal function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 mg single dose · subcutaneousAs given in this study (human).
Measurements
Cmax ratio vs healthy subjects
≈ 2.08 fold
end-stage renal disease vs healthy subjects
Source sentences
Summary
Area under the concentration versus time curve extrapolated to infinity (AUCinf) and maximum plasma concentration (Cmax) of teduglutide in subjects with end-stage renal disease were approximately 2.59- and 2.08-fold higher, respectively, than those of healthy subjects.
4 context sentences(design, population, supporting numbers)
Summary · context
Teduglutide plasma concentrations were measured using a validated liquid chromatography method with tandem mass spectrometric detection, and the primary pharmacokinetic variables (AUCinf and Cmax) were calculated.
Summary · context
This was an open-label study with six parallel groups (6 subjects each).
Summary · context
Three groups with renal impairment (moderate, severe and end-stage renal disease) were compared to healthy subjects with normal renal function, which were matched to the renal-impaired subjects with respect to demographics.
Summary · context
A single dose of 10 mg teduglutide was subcutaneously administered to each subject.
Report a problemFND-2318796502
03HumanNon-randomized trialPharmacokinetics
In subjects with moderate renal impairment, teduglutide AUCinf was slightly higher than in healthy subjects.
In plain wordsIn subjects with moderate renal impairment, teduglutide exposure was slightly higher than in healthy subjects.
Peptide
Teduglutide
Outcome
IncreaseAUCinf in moderate renal impairment
Study
n: not reported in source
Comparator
Healthy subjects with normal renal function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 mg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
The AUCinf and Cmax were also slightly higher in subjects with moderate and severe renal impairment.
4 context sentences(design, population, supporting numbers)
Summary · context
Teduglutide plasma concentrations were measured using a validated liquid chromatography method with tandem mass spectrometric detection, and the primary pharmacokinetic variables (AUCinf and Cmax) were calculated.
Summary · context
This was an open-label study with six parallel groups (6 subjects each).
Summary · context
Three groups with renal impairment (moderate, severe and end-stage renal disease) were compared to healthy subjects with normal renal function, which were matched to the renal-impaired subjects with respect to demographics.
Summary · context
A single dose of 10 mg teduglutide was subcutaneously administered to each subject.
Report a problemFND-2318796503
04HumanNon-randomized trialPharmacokinetics
In subjects with moderate renal impairment, teduglutide Cmax was slightly higher than in healthy subjects.
In plain wordsIn subjects with moderate renal impairment, peak teduglutide levels were slightly higher than in healthy subjects.
Peptide
Teduglutide
Outcome
IncreaseCmax in moderate renal impairment
Study
n: not reported in source
Comparator
Healthy subjects with normal renal function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 mg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
The AUCinf and Cmax were also slightly higher in subjects with moderate and severe renal impairment.
4 context sentences(design, population, supporting numbers)
Summary · context
Teduglutide plasma concentrations were measured using a validated liquid chromatography method with tandem mass spectrometric detection, and the primary pharmacokinetic variables (AUCinf and Cmax) were calculated.
Summary · context
This was an open-label study with six parallel groups (6 subjects each).
Summary · context
Three groups with renal impairment (moderate, severe and end-stage renal disease) were compared to healthy subjects with normal renal function, which were matched to the renal-impaired subjects with respect to demographics.
Summary · context
A single dose of 10 mg teduglutide was subcutaneously administered to each subject.
Report a problemFND-2318796504
05HumanNon-randomized trialPharmacokinetics
In subjects with severe renal impairment, teduglutide AUCinf was slightly higher than in healthy subjects.
In plain wordsIn subjects with severe renal impairment, teduglutide exposure was slightly higher than in healthy subjects.
Peptide
Teduglutide
Outcome
IncreaseAUCinf in severe renal impairment
Study
n: not reported in source
Comparator
Healthy subjects with normal renal function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 mg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
The AUCinf and Cmax were also slightly higher in subjects with moderate and severe renal impairment.
4 context sentences(design, population, supporting numbers)
Summary · context
Teduglutide plasma concentrations were measured using a validated liquid chromatography method with tandem mass spectrometric detection, and the primary pharmacokinetic variables (AUCinf and Cmax) were calculated.
Summary · context
This was an open-label study with six parallel groups (6 subjects each).
Summary · context
Three groups with renal impairment (moderate, severe and end-stage renal disease) were compared to healthy subjects with normal renal function, which were matched to the renal-impaired subjects with respect to demographics.
Summary · context
A single dose of 10 mg teduglutide was subcutaneously administered to each subject.
Report a problemFND-2318796505
06HumanNon-randomized trialPharmacokinetics
In subjects with severe renal impairment, teduglutide Cmax was slightly higher than in healthy subjects.
In plain wordsIn subjects with severe renal impairment, peak teduglutide levels were slightly higher than in healthy subjects.
Peptide
Teduglutide
Outcome
IncreaseCmax in severe renal impairment
Study
n: not reported in source
Comparator
Healthy subjects with normal renal function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 mg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
The AUCinf and Cmax were also slightly higher in subjects with moderate and severe renal impairment.
4 context sentences(design, population, supporting numbers)
Summary · context
Teduglutide plasma concentrations were measured using a validated liquid chromatography method with tandem mass spectrometric detection, and the primary pharmacokinetic variables (AUCinf and Cmax) were calculated.
Summary · context
This was an open-label study with six parallel groups (6 subjects each).
Summary · context
Three groups with renal impairment (moderate, severe and end-stage renal disease) were compared to healthy subjects with normal renal function, which were matched to the renal-impaired subjects with respect to demographics.
Summary · context
A single dose of 10 mg teduglutide was subcutaneously administered to each subject.
Report a problemFND-2318796506
07HumanNon-randomized trialPharmacokinetics
In healthy subjects, teduglutide pharmacokinetics were very similar in elderly subjects and those aged <65 years.
In plain wordsIn healthy subjects, teduglutide pharmacokinetics were very similar in elderly subjects and those younger than 65 years.
Peptide
Teduglutide
Outcome
No significant changePharmacokinetics by age
Study
n: not reported in source
Comparator
Healthy subjects aged <65 years
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 mg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
Comparison of healthy subjects aged <65 years with healthy elderly subjects revealed very similar pharmacokinetics in both subgroups.
4 context sentences(design, population, supporting numbers)
Summary · context
We found no effect of age on the pharmacokinetics of teduglutide in healthy subjects.
Summary · context
This was an open-label study with six parallel groups (6 subjects each).
Summary · context
Three groups with renal impairment (moderate, severe and end-stage renal disease) were compared to healthy subjects with normal renal function, which were matched to the renal-impaired subjects with respect to demographics.
Summary · context
A single dose of 10 mg teduglutide was subcutaneously administered to each subject.
Report a problemFND-2318796507

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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