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Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184652
First received: September 13, 2005
Last updated: January 23, 2017
Last verified: January 2017
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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 Intervention Model: Parallel Assignment Masking: Double (Participant, 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:
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 ]
Secondary Outcome Measures:
- Quality of Life
- Other markers of nutrition
| 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 to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184652
Locations
| Denmark | |
| Novo Nordisk Investigational Site | |
| København Ø, Denmark, 2100 | |
| Novo Nordisk Investigational Site | |
| Odense, Denmark, 5000 | |
| Novo Nordisk Investigational Site | |
| Århus N, Denmark, 8200 | |
| Germany | |
| Novo Nordisk Investigational Site | |
| Berlin, Germany, 13353 | |
| Novo Nordisk Investigational Site | |
| Heidelberg, Germany, 69115 | |
| Hong Kong | |
| Novo Nordisk Investigational Site | |
| Hong Kong, Hong Kong | |
| Israel | |
| Novo Nordisk Investigational Site | |
| 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 | |
| Poland | |
| Novo Nordisk Investigational Site | |
| Krakow, Poland, 31-501 | |
| Novo Nordisk Investigational Site | |
| Lublin, Poland, 20 - 094 | |
| Novo Nordisk Investigational Site | |
| Wolomin, Poland, 05-200 | |
| Singapore | |
| Novo Nordisk Investigational Site | |
| Singapore, Singapore, 119074 | |
| Sweden | |
| Novo Nordisk Investigational Site | |
| Göteborg, Sweden, 417 17 | |
| Switzerland | |
| Novo Nordisk Investigational Site | |
| Bern, Switzerland, 3010 | |
| United Kingdom | |
| Novo Nordisk Investigational Site | |
| 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 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR 1452) | Novo Nordisk A/S |
More Information
Additional Information:
Publications:
| 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: | January 23, 2017 |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on September 21, 2017