IGF-1 GENERATION TEST IN CHILDREN WITH CHRONIC KIDNEY FAILURE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this research study is to develop a standardized IGF-I generation test that can be used as a marker for growth hormone insensitivity in children with chronic kidney disease. The primary outcome variable that will be used to examine growth hormone responsiveness in children with CKD will be the stimulated IGF-I levels generated in response to exogenous growth hormone (Nutropin AQ). All subjects will receive both the 0.025 mg/kg/day and 0.5 mg/kg/day doses of growth hormone for seven days each. Half of the subjects will be randomized to receive the 0.025 mg/kg/day dose first followed by the 0.05 mg/kg/day dose, and the other half of subjects will be randomized to receive the 0.05 mg/kg/day dose first followed by the 0.025 mg/kg/day dose. IGF-I concentrations will be measured in all subjects on Days 1, 5 and 8 during the treatment with each of the two dose levels. It is anticipated that these IGF-I levels will positively correlate to annualized height velocity. Subjects with an annualized height velocity < 5.7 cm at Month 6 will undergo an additional IGF generation test on Days 1, 5 and 8 during the initial week of treatment with a higher dose of 0.1 mg/kg/day.