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IGF-1 Generation Test in Children With Chronic Kidney Disease
Sponsor study identifier
interventional
17
1 country
8
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2008
Actual (reported)Study Completion
May 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 14, 2005
Actual (reported)September 21, 2005
Actual (reported)May 2008
Actual (reported)May 2010
Actual (reported)October 26, 2011
Actual (reported)The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)
We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).
Day 1 & Day 8
Change in Height at 56 Weeks
week 1, week 56
This arm will receive Low dose of growth hormone (GH) (Nutropin AQ), for 7 days in a cross over design. Low dose GH will be 0.025 mg/kg/day. This will be followed by 2 weeks of wash out, then subjects will receive and the standard dose of Nutropin AQ (GH) at 0.05 mg/kg/dose given subcutaneously for another 7 days. IGF-I levels are measured after 7 days of the Low and the Standard dose of GH. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months and re-evaluated. If growth is adequate then subjects will continue on standard dose of GH for another 6 months for a total of 12 months.
This arm will receive Standard dose of growth hormone (GH) (Nutropin AQ), for 7 days in a cross over design. Standard dose GH will be 0.5 mg/kg/day. This will be followed by 2 weeks of wash out, then subjects will receive and the Low dose of Nutropin AQ (GH) at 0.025 mg/kg/dose given subcutaneously for another 7 days. IGF-I levels are measured after 7 days of the Low and the Standard dose of GH. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months and re-evaluated. If growth is adequate then subjects will continue on standard dose of GH for another 6 months for a total of 12 months.
Nutropin AQ
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Loma Linda UMC & Children's Hospital
Loma Linda, California, 92350, United States
University of California in Los Angeles (UCLA)
Los Angeles, California, 90095-1752, United States
Stanford University Medical Center
Stanford, California, 94305-5208, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
UT Houston Medical School
Buckway CK, Guevara-Aguirre J, Pratt KL, Burren CP, Rosenfeld RG. The IGF-I generation test revisited: a marker of GH sensitivity. J Clin Endocrinol Metab. 2001 Nov;86(11):5176-83. doi: 10.1210/jcem.86.11.8019.
Al-Uzri A, Swinford RD, Nguyen T, Jenkins R, Gunsul A, Kachan-Liu SS, Rosenfeld R. The utility of the IGF-I generation test in children with chronic kidney disease. Pediatr Nephrol. 2013 Dec;28(12):2323-33. doi: 10.1007/s00467-013-2570-0. Epub 2013 Sep 7.
Slow enrollment and the small number of participants in the study is the main limitation.
Amira Y Al-Uzri, M.D.
Oregon Health and Science University
17 participants (actual enrollment reported by the registry).
First Submitted
September 14, 2005
First Posted
September 21, 2005
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Houston, Texas, 77030, United States
University of Washington, Children's Hospital & Regional Medical Center
Seattle, Washington, 98105, United States
Primary Completion
May 2008
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
October 26, 2011
Results First Posted
October 26, 2011
Record last verified: 2011-10
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Source: ClinicalTrials.gov.
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