Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184652
First received: September 13, 2005
Last updated: November 18, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Designated as safety issue: No ]
  • Other markers of nutrition [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184652

Locations
Czech Republic
Prague, Czech Republic, 169 00
Denmark
København Ø, Denmark, 2100
France
Strasbourg, France, 67091
Germany
Heidelberg, Germany, 69115
Hong Kong
Hong Kong, Hong Kong
Israel
Kfar Saba, Israel, 44281
Poland
Wolomin, Poland, 05-200
Singapore
Singapore, Singapore, 119074
Sweden
Göteborg, Sweden, 417 17
Switzerland
Bern, Switzerland, 3010
United Kingdom
Coventry, United Kingdom, CV2 2DX
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Anders Dejgaard, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184652     History of Changes
Other Study ID Numbers: NN1606-1442
Study First Received: September 13, 2005
Last Updated: November 18, 2013
Health Authority: Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Poland: Ministry of Health
Singapore: Health Sciences Authority
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 20, 2014