Status:
COMPLETED
A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Kidney Failure, Chronic
Growth Hormone Deficiency
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
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 grow...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00212758
Start Date
January 1 2005
End Date
May 1 2010
Last Update
October 26 2011
Active Locations (8)
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1
Loma Linda UMC & Children's Hospital
Loma Linda, California, United States, 92350
2
University of California in Los Angeles (UCLA)
Los Angeles, California, United States, 90095-1752
3
Stanford University Medical Center
Stanford, California, United States, 94305-5208
4
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227