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

February 23, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-075
        • Novo Nordisk Investigational Site
      • Lisboa, Portugal, 1649-035
        • Novo Nordisk Investigational Site
      • Lisboa, Portugal, 1160-045
        • Novo Nordisk Investigational Site
      • Porto, Portugal, 4200-319
        • Novo Nordisk Investigational Site
  • Spain
      • Badajoz, Spain, 06080
        • Novo Nordisk Investigational Site
      • Baracaldo, Spain, 48903
        • Novo Nordisk Investigational Site
      • Esplugues Llobregat, Spain, 08950
        • Novo Nordisk Investigational Site
      • Lugo, Spain, 27004
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28009
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28041
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29011
        • Novo Nordisk Investigational Site
      • Oviedo, Spain, 33006
        • Novo Nordisk Investigational Site
      • Pamplona, Spain, 31008
        • Novo Nordisk Investigational Site
      • San Sebastián, Spain
        • Novo Nordisk Investigational Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39008
        • Novo Nordisk Investigational Site
      • Santiago de Compostela, Spain, 15705
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk Investigational Site
      • Zaragoza, Spain, 50009
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
  • To be included in the trial, patients must meet all of the following inclusion criteria a.)-c.):
  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: after 1 year of treatment
after 1 year of treatment

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 1998

Primary Completion (Actual)

December 21, 2005

Study Completion (Actual)

December 21, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHCRF/E/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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