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

Primary Purpose

Chronic Kidney Disease, Chronic Renal Insufficiency

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
somatropin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

9 Months - 15 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
February 23, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00184769
Brief Title
Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 29, 1998 (Actual)
Primary Completion Date
December 21, 2005 (Actual)
Study Completion Date
December 21, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Chronic Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1160-045
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Esplugues Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
San Sebastián
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santa Cruz de Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20522533
Citation
Santos F, Moreno ML, Neto A, Ariceta G, Vara J, Alonso A, Bueno A, Afonso AC, Correia AJ, Muley R, Barrios V, Gomez C, Argente J. Improvement in growth after 1 year of growth hormone therapy in well-nourished infants with growth retardation secondary to chronic renal failure: results of a multicenter, controlled, randomized, open clinical trial. Clin J Am Soc Nephrol. 2010 Jul;5(7):1190-7. doi: 10.2215/CJN.07791109. Epub 2010 Jun 3.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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