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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00184652
Other study ID # NN1606-1442
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated January 23, 2017
Start date April 2003
Est. completion date September 2005

Study information

Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- ESRD patients

Exclusion Criteria:

- Diabetes Mellitus

- Severe and Malignant diseases

- Patients in Intensive Care Units

Study Design


Intervention

Drug:
somatropin


Locations

Country Name City State
Denmark Novo Nordisk Investigational Site Århus N
Denmark Novo Nordisk Investigational Site København Ø
Denmark Novo Nordisk Investigational Site Odense
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Heidelberg
Hong Kong Novo Nordisk Investigational Site Hong Kong
Israel Novo Nordisk Investigational Site Holon
Israel Novo Nordisk Investigational Site Kfar Saba
Israel Novo Nordisk Investigational Site Petach Tikva
Israel Novo Nordisk Investigational Site Ramat Gan
Israel Novo Nordisk Investigational Site Tel-Aviv
Israel Novo Nordisk Investigational Site Tzriffin
Poland Novo Nordisk Investigational Site Krakow
Poland Novo Nordisk Investigational Site Lublin
Poland Novo Nordisk Investigational Site Wolomin
Singapore Novo Nordisk Investigational Site Singapore
Sweden Novo Nordisk Investigational Site Göteborg
Switzerland Novo Nordisk Investigational Site Bern
United Kingdom Novo Nordisk Investigational Site Birmingham
United Kingdom Novo Nordisk Investigational Site Coventry
United Kingdom Novo Nordisk Investigational Site Glasgow
United Kingdom Novo Nordisk Investigational Site Liverpool
United Kingdom Novo Nordisk Investigational Site Manchester
United Kingdom Novo Nordisk Investigational Site Newcastle
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Swansea

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Denmark,  Germany,  Hong Kong,  Israel,  Poland,  Singapore,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Feldt-Rasmussen B, Lange M, Sulowicz W, Gafter U, Lai KN, Wiedemann J, Christiansen JS, El Nahas M; APCD Study Group.. Growth hormone treatment during hemodialysis in a randomized trial improves nutrition, quality of life, and cardiovascular risk. J Am So — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in surrogate markers of nutrition After 6 months treatment
Secondary Quality of Life
Secondary Other markers of nutrition
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