search
Back to results

Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease, End-Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
somatropin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ESRD patients Exclusion Criteria: Diabetes Mellitus Severe and Malignant diseases Patients in Intensive Care Units

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Change in surrogate markers of nutrition

Secondary Outcome Measures

Quality of Life
Other markers of nutrition

Full Information

First Posted
September 13, 2005
Last Updated
January 23, 2017
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT00184652
Brief Title
Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease
Official Title
The Effect of Norditropin® on Nutritional Status in Adult Patients in Chronic Haemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End-Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Change in surrogate markers of nutrition
Time Frame
After 6 months treatment
Secondary Outcome Measure Information:
Title
Quality of Life
Title
Other markers of nutrition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ESRD patients Exclusion Criteria: Diabetes Mellitus Severe and Malignant diseases Patients in Intensive Care Units
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novo Nordisk Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tzriffin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20 - 094
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Wolomin
ZIP/Postal Code
05-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
417 17
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L69 3GA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 0HZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17554147
Citation
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 Soc Nephrol. 2007 Jul;18(7):2161-71. doi: 10.1681/ASN.2006111207. Epub 2007 Jun 6.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

We'll reach out to this number within 24 hrs