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NCT00212758 · ClinicalTrials.gov registry record · Phase 4
A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
A Phase 4 study of Kidney Failure, Chronic and Growth Hormone Deficiency, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 8
- Study locations
NCT00212758 is a Phase 4 study of Kidney Failure, Chronic and Growth Hormone Deficiency that has completed, run by Oregon Health and Science University. The registered enrollment target is 17 participants, below the 331-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 4 states.
The verdict
NCT00212758, a Phase 4 study of Kidney Failure, Chronic and Growth Hormone Deficiency, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 8
- Study locations
Study Summary
Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has been shown to be helpful in treating children with chronic kidney disease who fail to grow. The amount of growth that is seen in children treated with growth hormone varies widely for unknown reasons. Growth hormone works by producing another hormone in the liver called insulin-like growth factor-1, or IGF-1 for short. IGF-1 stimulates the bones to grow. The amount of IGF-1 in the blood may directly affect the amount of growth in each child. At this time, growth hormone therapy in children depends on giving a certain dose of growth hormone for each child based on his or her weight. If after 3-6 months on this dose of growth hormone the change in height is not enough, then the dose of growth hormone is increased until enough growth is seen. This method of dosing of growth hormone may take a long time and is complicated and time-consuming. The purpose of this study is to measure the amount of IGF-1 produced by the body as a result of giving 2 different doses of growth hormone in children for 7 days only. The study investigator hopes to find the most favorable level of IGF-1 generated after 7 days of growth hormone that correlates with good growth of children with kidney disease. Then instead of dosing growth hormone by weight, like is done now, researchers can dose growth hormone by the amount of IGF-1 that the body produces. Being able to dose more effectively will save valuable time for the child to grow and will shorten the overall duration of growth hormone therapy. The investigators will also determine the effect of inflammatory cytokines Il-6 and TNF-alpha on growth hormone insensitivity and hence IGF-1 generation test in the same population.
Conditions Studied
Interventions
- DRUG Nutropin AQ
Study Locations (8)
California
- Loma Linda UMC & Children's Hospital - Loma Linda
- University of California in Los Angeles (UCLA) - Los Angeles
- Stanford University Medical Center - Stanford
Oregon
- Legacy Emanuel Children's Hospital - Portland
- Oregon Health & Science University - Portland
Texas
- Texas Children's Hospital - Houston
- UT Houston Medical School - Houston
Washington
- University of Washington, Children's Hospital & Regional Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-01 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00212758
The ClinicalTrials.gov registry entry for NCT00212758 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 331-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (95% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Kidney Failure, Chronic appearing as the primary indexed condition, and to 1 intervention - of which Nutropin AQ is the first listed.
NCT00212758 reports 8 study locations spanning 4 distinct geographic areas - top geographies include California, Oregon, Texas.
Frequently Asked Questions
What is clinical trial NCT00212758 about?
NCT00212758 is a clinical study titled "A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood". Treatment with growth hormone (GH; a hormone made by the body that stimulates growth) has been shown to be helpful in treating children with chronic kidney disease who fail to grow. The amount of growth that is seen in children treated with growth hormone varies widely for unknown reasons. Growth ho...
What is the current status of trial NCT00212758?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2005-01. Estimated completion is 2010-05.
What conditions does trial NCT00212758 study?
This clinical trial studies the following conditions: Kidney Failure, Chronic, Growth Hormone Deficiency.
What interventions are being tested in trial NCT00212758?
The interventions under investigation include: Nutropin AQ (DRUG).
Who is sponsoring clinical trial NCT00212758?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00212758 being conducted?
This trial has 8 study locations across California, Oregon, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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