At a glance
ClinicalIndex Comparison Record- ✓Age 2–18 years with chronic renal failure
- ✓Estimated creatinine clearance 25–75 mL/min/1.73 m² by Schwartz formula
- ✓Growth impairment: height SDS < −1.88 or annual height velocity SD < −2.0 for age/sex over preceding 6 months
- ✓No prior growth hormone therapy
- ✕On dialysis or kidney transplant recipients
- ✕Significant renal osteodystrophy or PTH > 500 pg/mL over preceding 3 months
- ✕Diabetes mellitus
- ✕History of malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
IGF-1 Generation Test in Children With Chronic Kidney Disease
In Brief
A Phase 4 clinical trial evaluating Nutropin AQ for Kidney Failure, Chronic and Growth Hormone Deficiency. Completed, enrolled 17 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Nutropin AQ