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Sponsors and Collaborators: |
Oregon Health and Science University Genentech |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00212758 |
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 different doses of growth hormone in children. The study investigator hopes to find the most favorable level of IGF-1 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.
We 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.
Condition | Intervention | Phase |
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Kidney Failure, Chronic Growth Hormone Deficiency |
Drug: Nutropin AQ |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study |
Official Title: | IGF-1 Generation Test in Children With Chronic Kidney Disease |
Enrollment: | 18 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
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low , standard
There will be 2 arms in the study who will be randomized in a cross over design. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months.
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Drug: Nutropin AQ
6 months of therapy of Nutropin AQ at 0.05 mg/kg/day SQ will be given
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The study will involve 30 children with chronic kidney disease and failure to grow. The study will last for 14 months. There will be a screening clinic visit if the child qualifies for the study, Week -8. Each clinic visit will include, getting a medical history, a physical exam, and a blood test. Also an x-ray of the wrist to calculate bone age. If abnormal blood values are found as a result of kidney failure then an attempt will be made to correct them over the next 2 months before enrollment in the study.
Also children will be asked to keep track of all of the foods for 3 days every month during the study. A study nutritionist will call them once each month to go over the food diary.
At study Week -4, children will come again for a clinic visit. Then at Week 0 of the study, a decision will be made randomly based on the level of kidney function to what dose of growth hormone a child will receive. This will be either a low dose of growth hormone or a high dose of growth hormone.
At the Week 1 and Week 4 visits, children will come for a clinic visit. Children will take growth hormone (through a needle under the skin) every night for a full 7 days during each of the two weeks. In the mornings before the 1st and after the 7th dose both weeks, children will have their blood drawn to check IGF-1 levels.
During Weeks 2 and 3, children will not take any growth hormone in order to allow the body to clear, or "wash-out", the medication from the system before Week 4.
At Week 5, children will begin taking growth hormone each evening and continue to do so every day through Week 28. Then, for Weeks 29 and 30, children will have another "wash-out" period with no growth hormone treatment.
At Week 31, blood will be drawn in the mornings before the 1st and after the 7th dose of growth hormone treatment. From Week 32 on, children will take growth hormone every evening and continue to do so through Week 56, the end of the study.
Also at week 1, skin fold measurements to assess body fat will be done on all subjects. A DEXA scan, a test that measures body fat and muscle mass will be done on the older children in the study on an optional basis on Weeks 1, 28 and 56. Another wrist X-ray for bone age will be repeated at 56 weeks of the study.
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Loma Linda UMC & Children's Hospital | |
Loma Linda, California, United States, 92350 | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5208 | |
University of California in Los Angeles (UCLA) | |
Los Angeles, California, United States, 90095-1752 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
Legacy Emanuel Children's Hospital | |
Portland, Oregon, United States, 97227 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
UT Houston Medical School | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
University of Washington, Children's Hospital & Regional Medical Center | |
Seattle, Washington, United States, 98105 |
Principal Investigator: | Amira Y Al-Uzri, M.D. | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Darlene Kitterman/ Director of investigator support and Integration services ) |
Study ID Numbers: | Genentech # 303-MO1 |
Study First Received: | September 14, 2005 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00212758 |
Health Authority: | United States: Institutional Review Board |
Short stature children kidney failure, chronic Growth |
Dwarfism Bone Diseases, Endocrine Hypopituitary dwarfism Hypothalamic Diseases Renal Insufficiency Pituitary Diseases Kidney Failure, Chronic Endocrine System Diseases Central Nervous System Diseases Dwarfism, Pituitary Brain Diseases |
Bone Diseases Growth hormone deficiency Urologic Diseases Musculoskeletal Diseases Hypopituitarism Renal Insufficiency, Chronic Bone Diseases, Developmental Endocrinopathy Kidney Diseases Kidney Failure |
Nervous System Diseases |