Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: September 13, 2005
Last updated: November 18, 2013
Last verified: November 2013
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 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 ]

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ESRD patients

Exclusion Criteria:

  • Diabetes Mellitus
  • Severe and Malignant diseases
  • Patients in Intensive Care Units
  Contacts and Locations
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Please refer to this study by its identifier: NCT00184652

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00184652     History of Changes
Other Study ID Numbers: NN1606-1442 
Study First Received: September 13, 2005
Last Updated: November 18, 2013

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases processed this record on January 23, 2017