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Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00184652
First received: September 13, 2005
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  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 Growth Hormone on Nutritional Status in Adult Patients With End-stage Renal Disease.

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Locations
China
Hong Kong, China
Czech Republic
Prague, Czech Republic
Denmark
Copenhagen, Denmark
France
STRASBOURG Cedex, France
Germany
Heidelberg, Germany
Israel
Kfar Saba, Israel
Poland
Lublin, Poland
Singapore
Singapore, Singapore
Sweden
Göteborg, Sweden
Switzerland
Bern, Switzerland
United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Anders Dejgaard, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, 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: July 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013