NCT00184769|CompletedPhase 4

Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.

Open Randomized Trial Examining the Growth and Safety Effects of Treatment With Recombinant Growth Hormone on Infants Aged 1 to 2 Years With Growth Retardation Secondary to Chronic Renal Insufficiency

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

GHCRF/E/2

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredSep 2005

StartedJan 1998

CompletionDec 2005

Brief Summary

This trial is conducted in Europe. Objective(s): To evaluate the effect of human growth hormone on infants aged 1 to 2 years with chronic renal insufficiency (CRI) and growth retardation despite an adequate dietary intake. Trial Design: This is an open, parallel group clinical trial with a duration of one year, in which period 50% of patients will receive GH treatment and the other 50% will act as a control group, without treatment. Trial Population: The trial will involve a total of 16 infants aged from 12±3 to 24 months suffering chronic renal insufficiency (Glomerular Filtration Rate less than 60 ml/min/1.73 m2), and growth failure and undergoing conservative treatment or peritoneal dialysis. Include the key inclusion and exclusion criteria.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_4

Timeline

Completed

Started Jan 1998

Longer than P75 for phase_4

Geographic Reach

2 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.9 years study duration

Study Start

First participant enrolled

January 29, 1998

Completed

7.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2005

Completed

Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

7.9 years

First QC Date

September 13, 2005

Last Update Submit

February 23, 2017

Conditions

Chronic Kidney Disease Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

To evaluate the effect of growth hormone on infants aged 1 to 2 years with CRI and growth retardation growth retardation despite an adequate dietary intake
after 1 year of treatment

Secondary Outcomes (1)

Secondary objectives are to assess the safety of rhGH treatment in these infants. Safety assessment will include evaluation of renal function, Bone, IGF-I, IGFBP3 and psychological development

Interventions

somatropinDRUG

Eligibility Criteria

Age9 Months - 15 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
a.) Male or female infants with a chronological age of 12 ± 3 months
b.) Chronic renal insufficiency with Glomerular Filtration Rate less than 60 ml/min./1.73m2, according to the method used routinely in each participating center
c.) Growth retardation documented at the start of the trial, according to the following criteria: Length less than -2 SDS by chronological age and sex and linear growth velocity \<P50 according to the Hernández standards and to Lubchenko in the case of infants born prematurely (\<37 weeks)
Conservative treatment or chronic peritoneal dialysis
Euthyroid
The parent or guardian must give informed consent to the child's participation in the study before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
Optimal nutritional management criteria met
Appropriate metabolic control for severe hyperparathyroidism, hydroelectrolyte balance, acid-base balance and calcium-phosphorus balance

You may not qualify if:

Any primary endocrinological disorder and severe renal osteodystrophy.Other causes, apart from CRI, giving rise to growth retardation.Hydrocephalus.
Known or suspected allergy to the trial product or related products.
Treatment with corticosteroids within the last six months.
Renal disease due to the Fanconi syndrome or to oxalosis (except if not under dialysis).
Known or suspected malignancy.

Contact the study team to confirm eligibility.