Longitudinal infusion of a complex of insulin-like growth factor-I and IGF-binding protein-3 in five preterm infants: pharmacokinetics and short-term safety.

Ley D, Hansen-Pupp I, Niklasson A, Domellöf M, Friberg LE, Borg J, Löfqvist C, Hellgren G, Smith LE, Hård AL, Hellström A

Pediatric research24 Oct 2012Cited by 54 (Europe PMC)

PMID23095978PMCIDPMC4028624DOI10.1038/pr.2012.146PepBankPUB-23095978

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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 study6

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialPharmacokinetics
In preterm infants, rhIGF-I/rhIGFBP-3 increased serum IGF-I versus model-predicted endogenous levels.
In plain wordsIn preterm infants, the complex raised serum IGF-I above predicted natural levels.
Peptide
IGF-1 (mecasermin)
Outcome
IncreaseSerum IGF-I
Study
n = 5
Comparator
Model-predicted endogenous levels
Outcome group
Pharmacokinetics · Endocrine and hormones
Studied dose
21-111 µg/kg/24 h · intravenous · median 168 h (range 47-168 h)As given in this study (human).
Measurements
P value for serum IGF-I concentration
< 0.001 p value
rhIGF-I/rhIGFBP-3 treatment versus model-predicted endogenous levels
Source sentences
Summary
Treatment with rhIGF-I/rhIGFBP-3 was associated with higher serum IGF-I and IGFBP-3 concentrations (P < 0.001) than model-predicted endogenous levels.
4 context sentences(design, population, supporting numbers)
Summary · context
In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Summary · context
Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 µg/kg/24 h.
Summary · context
five infants (three girls)
Summary · context
received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Report a problemFND-2309597801
02HumanNon-randomized trialPharmacokinetics
In preterm infants, half of IGF-I samples during complex infusion were within target, with others above or below.
In plain wordsIn preterm infants, half of IGF-I samples during complex infusion reached the target range.
Peptide
IGF-1 (mecasermin)
Outcome
Not applicableIGF-I target attainment
Study
n = 5
Outcome group
Pharmacokinetics · Endocrine and hormones
Studied dose
21-111 µg/kg/24 h · intravenous · median 168 h (range 47-168 h)As given in this study (human).
Measurements
Within target
50%
samples
Above target
5%
samples
Below target
45%
samples
IGF-I samples measured
74 samples
during study drug infusion
IGF-I samples within target range
37 samples
during study drug infusion
IGF-I samples above target range
4 samples
during study drug infusion
IGF-I samples below target range
33 samples
during study drug infusion
Source sentences
Summary
Of 74 IGF-I samples measured during study drug infusion, 37 (50%) were within the target range, 4 (5%) were above, and 33 (45%) were below.
4 context sentences(design, population, supporting numbers)
Summary · context
In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Summary · context
Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 µg/kg/24 h.
Summary · context
five infants (three girls)
Summary · context
received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Report a problemFND-2309597802
03HumanNon-randomized trialSafety outcome
In preterm infants receiving rhIGF-I/rhIGFBP-3, no hypoglycemia was recorded.
In plain wordsIn preterm infants receiving the complex, no low blood sugar was recorded.
Peptide
IGF-1 (mecasermin)
Outcome
Not applicableHypoglycemia
Study
n = 5
Outcome group
Adverse events · Metabolic and weight
Studied dose
21-111 µg/kg/24 h · intravenous · median 168 h (range 47-168 h)As given in this study (human).
Source sentences
Summary
No hypoglycemia or other adverse effects were recorded.
4 context sentences(design, population, supporting numbers)
Summary · context
In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Summary · context
Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 µg/kg/24 h.
Summary · context
five infants (three girls)
Summary · context
received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Report a problemFND-2309597804
04HumanNon-randomized trialSafety outcome
In preterm infants receiving rhIGF-I/rhIGFBP-3, no other adverse effects were recorded.
In plain wordsIn preterm infants receiving the complex, no other adverse effects were recorded.
Peptide
IGF-1 (mecasermin)
Outcome
Not applicableOther adverse effects
Study
n = 5
Outcome group
Adverse events · Whole body
Studied dose
21-111 µg/kg/24 h · intravenous · median 168 h (range 47-168 h)As given in this study (human).
Source sentences
Summary
No hypoglycemia or other adverse effects were recorded.
4 context sentences(design, population, supporting numbers)
Summary · context
In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Summary · context
Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 µg/kg/24 h.
Summary · context
five infants (three girls)
Summary · context
received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Report a problemFND-2309597805
05HumanNon-randomized trialPharmacokinetics
In preterm infants, rhIGF-I/rhIGFBP-3 raised serum IGFBP-3 above model-predicted endogenous levels.
In plain wordsIn preterm infants, the complex raised serum IGFBP-3 above predicted natural levels.
Peptide
IGF-1 (mecasermin)
Outcome
IncreaseSerum IGFBP-3
Study
n = 5
Comparator
Model-predicted endogenous levels
Outcome group
Pharmacokinetics · Endocrine and hormones
Studied dose
21-111 µg/kg/24 h · intravenous · median 168 h (range 47-168 h)As given in this study (human).
Measurements
P value for serum IGFBP-3 concentration
< 0.001 p value
rhIGF-I/rhIGFBP-3 treatment versus model-predicted endogenous levels
Source sentences
Summary
Treatment with rhIGF-I/rhIGFBP-3 was associated with higher serum IGF-I and IGFBP-3 concentrations (P < 0.001) than model-predicted endogenous levels.
4 context sentences(design, population, supporting numbers)
Summary · context
In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Summary · context
Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 µg/kg/24 h.
Summary · context
five infants (three girls)
Summary · context
received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Report a problemFND-2309597806

Studies that did not test the peptide alone1

In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking IGF-1 (mecasermin).

06Computer modelNot a test of IGF-1 (mecasermin) aloneIn silicoPharmacokinetics
A model predicted that rhIGF-I/rhIGFBP-3 at 75-100 µg/kg/24 h would achieve intrauterine IGF-I levels in a 1,000 g infant.
In plain wordsA model predicted the complex dose needed to reach intrauterine IGF-I levels in an infant.
Peptide
IGF-1 (mecasermin)
Outcome
Not applicablePredicted dose
Study
n: not reported in source
Outcome group
Pharmacokinetics · Endocrine and hormones
Source sentences
Summary
The predicted dose of rhIGF-I/rhIGFBP-3 required to establish circulating levels of IGF-I within the intrauterine range in a 1,000 g infant was 75-100 µg/kg/24 h.
2 context sentences(design, population, supporting numbers)
Summary · context
In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3.
Summary · context
Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 µg/kg/24 h.
In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).
Report a problemFND-2309597803

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT01096784

IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

Shiren = 12118 Jun 2010 to 30 Mar 2016

Retinopathy of Prematurity (ROP)

Trial page ClinicalTrials.govUpdated 14 Jun 2021

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
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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