A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
IGF-1 Generation Test in Children With Chronic Kidney Disease
1 other identifier
interventional
17
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2005
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
October 26, 2011
CompletedOctober 26, 2011
October 1, 2011
3.3 years
September 14, 2005
July 22, 2011
October 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change in Height at 56 Weeks
week 1, week 56
Study Arms (2)
Low- Standard GH dose
ACTIVE COMPARATORThis 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.
Standard-Low GH dose (7 Days)
ACTIVE COMPARATORThis 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.
Interventions
Nutropin AQ
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Genentech, Inc.collaborator
Study Sites (8)
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
Related Publications (2)
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.
PMID: 11701674BACKGROUNDAl-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.
PMID: 24013497DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Slow enrollment and the small number of participants in the study is the main limitation.
Results Point of Contact
- Title
- Dr. Amira Al-Uzri
- Organization
- Oregon Health & Science University
Study Officials
- PRINCIPAL INVESTIGATOR
Amira Y Al-Uzri, M.D.
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 21, 2005
Study Start
January 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2010
Last Updated
October 26, 2011
Results First Posted
October 26, 2011
Record last verified: 2011-10