Observational Prospective Study on Patients Treated With Norditropin®

Chronic Kidney Disease Clinical Trial

Official title:

NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960128
• Other study ID #: GHLIQUID-3676
• Secondary ID: 2008-001674-32
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: October 11, 2017
• Start date: April 1, 2006
• Est. completion date: December 31, 2016

Study information

• Verified date: October 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21249
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Judged by the physician as per the Norditropin® label

Exclusion Criteria:

• Judged by the physician as per the Norditropin® label

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Chronic Kidney Disease
• Chronic Renal Insufficiency
• Disease
• Dwarfism, Pituitary
• Endocrine System Diseases
• Foetal Growth Problem
• Genetic Diseases, Inborn
• Genetic Disorder
• Gonadal Dysgenesis
• Growth Hormone Deficiency in Children
• Growth Hormone Disorder
• Kidney Diseases
• Noonan Syndrome
• Primary Ovarian Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Small for Gestational Age
• Syndrome
• Turner Syndrome

Intervention

Drug:
• somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.
• somatropin
The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.

Locations

Country	Name	City	State
Argentina	Novo Nordisk Investigational Site	Prov. de Buenos Aires
Belgium	Novo Nordisk Investigational Site	Brussels
Czechia	Novo Nordisk Investigational Site	Prague
Denmark	Novo Nordisk Investigational Site	Copenhagen S
Finland	Novo Nordisk Investigational Site	Espoo
France	Novo Nordisk Investigational Site	Paris La défense cedex
Germany	Novo Nordisk Investigational Site	Mainz
Hungary	Novo Nordisk Investigational Site	Budapest
Ireland	Novo Nordisk Investigational Site	Dublin 2
Israel	Novo Nordisk Investigational Site	Kfar Saba
Italy	Novo Nordisk Investigational Site	Rome
Lithuania	Novo Nordisk Investigational Site	Vilnius
Luxembourg	Novo Nordisk Investigational Site	Luxembourg
Netherlands	Novo Nordisk Investigational Site	Alphen a/d Rijn
Norway	Novo Nordisk Investigational Site	Rud
Russian Federation	Novo Nordisk Investigational Site	Moscow
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Serbia	Novo Nordisk Investigational Site	Belgrade
Slovenia	Novo Nordisk Investigational Site	Ljubljana
Spain	Novo Nordisk Investigational Site	Madrid
Sweden	Novo Nordisk Investigational Site	Malmö
Switzerland	Novo Nordisk Investigational Site	Zurich
United Kingdom	Novo Nordisk Investigational Site	Crawley

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Argentina,  Belgium,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Lithuania,  Luxembourg,  Netherlands,  Norway,  Russian Federation,  Saudi Arabia,  Serbia,  Slovenia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (7)

Blankenstein O, Snajderova M, Blair J, Pournara E, Pedersen BT, Petit IO. Real-life GH dosing patterns in children with GHD, TS or born SGA: a report from the NordiNet® International Outcome Study. Eur J Endocrinol. 2017 Aug;177(2):145-155. doi: 10.1530/E — View Citation

Christesen HT, Pedersen BT, Pournara E, Petit IO, Júlíusson PB. Short Stature: Comparison of WHO and National Growth Standards/References for Height. PLoS One. 2016 Jun 9;11(6):e0157277. doi: 10.1371/journal.pone.0157277. eCollection 2016. — View Citation

Höybye C, Sävendahl L, Christesen HT, Lee P, Pedersen BT, Schlumpf M, Germak J, Ross J. The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based — View Citation

Lee PA, Sävendahl L, Oliver I, Tauber M, Blankenstein O, Ross J, Snajderova M, Rakov V, Pedersen BT, Christesen HT. Comparison of response to 2-years' growth hormone treatment in children with isolated growth hormone deficiency, born small for gestational — View Citation

Sävendahl L, Blankenstein O, Oliver I, Christesen HT, Lee P, Pedersen BT, Rakov V, Ross J. Gender influences short-term growth hormone treatment response in children. Horm Res Paediatr. 2012;77(3):188-94. doi: 10.1159/000337570. Epub 2012 Apr 12. — View Citation

Sävendahl L, Pournara E, Pedersen BT, Blankenstein O. Is safety of childhood growth hormone therapy related to dose? Data from a large observational study. Eur J Endocrinol. 2016 May;174(5):681-91. doi: 10.1530/EJE-15-1017. Epub 2016 Feb 22. — View Citation

Weber MM, Biller BM, Pedersen BT, Pournara E, Christiansen JS, Höybye C. The effect of growth hormone (GH) replacement on blood glucose homeostasis in adult nondiabetic patients with GH deficiency: real-life data from the NordiNet(®) International Outcome — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Norditropin® treatment on height gain (change in height) in children		Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Primary	Effect of Norditropin® treatment on body weight and body composition in adults		Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Secondary	Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children		Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.
Secondary	Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults		Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.

External Links

•   Clinical Trials at Novo Nordisk