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Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184652
First Posted: September 16, 2005
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney disease are treated with growth hormone to assess effect on nutritional status.

Condition Intervention Phase
Chronic Kidney Disease End-Stage Renal Disease Drug: somatropin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Norditropin® on Nutritional Status in Adult Patients in Chronic Haemodialysis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in surrogate markers of nutrition [ Time Frame: After 6 months treatment ]

Secondary Outcome Measures:
  • Quality of Life
  • Other markers of nutrition

Enrollment: 140
Study Start Date: April 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ESRD patients

Exclusion Criteria:

  • Diabetes Mellitus
  • Severe and Malignant diseases
  • Patients in Intensive Care Units
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184652


Locations
Denmark
Novo Nordisk Investigational Site
København Ø, Denmark, 2100
Novo Nordisk Investigational Site
Odense, Denmark, 5000
Novo Nordisk Investigational Site
Århus N, Denmark, 8200
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Heidelberg, Germany, 69115
Hong Kong
Novo Nordisk Investigational Site
Hong Kong, Hong Kong
Israel
Novo Nordisk Investigational Site
Holon, Israel, 58100
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site
Petach Tikva, Israel, 49100
Novo Nordisk Investigational Site
Ramat Gan, Israel, 52621
Novo Nordisk Investigational Site
Tel-Aviv, Israel, 64239
Novo Nordisk Investigational Site
Tzriffin, Israel, 70300
Poland
Novo Nordisk Investigational Site
Krakow, Poland, 31-501
Novo Nordisk Investigational Site
Lublin, Poland, 20 - 094
Novo Nordisk Investigational Site
Wolomin, Poland, 05-200
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 119074
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 417 17
Switzerland
Novo Nordisk Investigational Site
Bern, Switzerland, 3010
United Kingdom
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B9 5SS
Novo Nordisk Investigational Site
Coventry, United Kingdom, CV2 2DX
Novo Nordisk Investigational Site
Glasgow, United Kingdom, G11 6NT
Novo Nordisk Investigational Site
Liverpool, United Kingdom, L69 3GA
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 0HZ
Novo Nordisk Investigational Site
Newcastle, United Kingdom, NE7 7DN
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S5 7AU
Novo Nordisk Investigational Site
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184652     History of Changes
Other Study ID Numbers: NN1606-1442
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency