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

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 Norditropin® on Nutritional Status in Adult Patients in Chronic Haemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Kidney Diseases

Drug Information available for: Somatropin

U.S. FDA Resources

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:

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

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 March 02, 2015

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