A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Chronic; Growth Hormone Deficiency
Intervention: Nutropin AQ (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s):
Amira Y Al-Uzri, M.D., Principal Investigator, Affiliation: Oregon Health and Science University
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.
Clinical Details
Official title: IGF-1 Generation Test in Children With Chronic Kidney Disease
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)
Secondary outcome: Change in Height at 56 Weeks
Detailed description:
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females between 2-18 years of age with chronic renal failure.
- Estimated creatinine clearance between 25-75 ml/min/1. 73 m2 calculated by the
Schwartz formula.
- Height standard deviation score (SDS) more than -1. 88 or annual height velocity SD of
more than - 2. 0 for age and sex for the preceding 6 months.
- No history of growth hormone therapy.
- Cystinosis subjects may qualify for the study if they meet other inclusion criteria
and have an estimated creatinine clearance of 25-75 ml/min/1. 73 m2.
- Bone age less than 16 years for boys and less than 13 years for girls.
- Subjects with chronic kidney failure who are off steroid therapy or other drugs that
interfere with growth for at least 6 months.
Exclusion Criteria:
- Subjects on dialysis and kidney transplant recipients.
- Patients with significant renal osteodystrophy or an intact parathyroid (PTH) level
more than 500 pg/ml over the last 3 months prior to enrollment.
- Diabetes mellitus.
- History of malignancy.
Locations and Contacts
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, Houston, Texas 77030, United States
University of Washington, Children's Hospital & Regional Medical Center, Seattle, Washington 98105, United States
Additional Information
Related publications: 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.
Starting date: January 2005
Last updated: October 22, 2011
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