Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

January 23, 2017 updated by: Novo Nordisk A/S

The Effect of Norditropin® on Nutritional Status in Adult Patients in Chronic Haemodialysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: somatropin

Study Type

Interventional

Enrollment (Actual)

140

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - København Ø, Denmark, 2100
    - Novo Nordisk Investigational Site
  - Odense, Denmark, 5000
    - Novo Nordisk Investigational Site
  - Århus N, Denmark, 8200
    - Novo Nordisk Investigational Site
Germany
- - Berlin, Germany, 13353
    - Novo Nordisk Investigational Site
  - Heidelberg, Germany, 69115
    - Novo Nordisk Investigational Site
Hong Kong
- - Hong Kong, Hong Kong
    - Novo Nordisk Investigational Site
Israel
- - Holon, Israel, 58100
    - Novo Nordisk Investigational Site
  - Kfar Saba, Israel, 44281
    - Novo Nordisk Investigational Site
  - Petach Tikva, Israel, 49100
    - Novo Nordisk Investigational Site
  - Ramat Gan, Israel, 52621
    - Novo Nordisk Investigational Site
  - Tel-Aviv, Israel, 64239
    - Novo Nordisk Investigational Site
  - Tzriffin, Israel, 70300
    - Novo Nordisk Investigational Site
Poland
- - Krakow, Poland, 31-501
    - Novo Nordisk Investigational Site
  - Lublin, Poland, 20 - 094
    - Novo Nordisk Investigational Site
  - Wolomin, Poland, 05-200
    - Novo Nordisk Investigational Site
Singapore
- - Singapore, Singapore, 119074
    - Novo Nordisk Investigational Site
Sweden
- - Göteborg, Sweden, 417 17
    - Novo Nordisk Investigational Site
Switzerland
- - Bern, Switzerland, 3010
    - Novo Nordisk Investigational Site
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Novo Nordisk Investigational Site
  - Coventry, United Kingdom, CV2 2DX
    - Novo Nordisk Investigational Site
  - Glasgow, United Kingdom, G11 6NT
    - Novo Nordisk Investigational Site
  - Liverpool, United Kingdom, L69 3GA
    - Novo Nordisk Investigational Site
  - Manchester, United Kingdom, M13 0HZ
    - Novo Nordisk Investigational Site
  - Newcastle, United Kingdom, NE7 7DN
    - Novo Nordisk Investigational Site
  - Sheffield, United Kingdom, S5 7AU
    - Novo Nordisk Investigational Site
  - Swansea, United Kingdom, SA6 6NL
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

ESRD patients

Exclusion Criteria:

Diabetes Mellitus
Severe and Malignant diseases
Patients in Intensive Care Units

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in surrogate markers of nutrition Time Frame: After 6 months treatment	After 6 months treatment

Secondary Outcome Measures

Outcome Measure
Quality of Life
Other markers of nutrition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)