Status:
TERMINATED
Effect of Growth Hormone on Leptin, Cytokines and Body Composition of Children With Growth Failure Due to Chronic Kidney Disease
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Circulating concentrations of cytokines, such as leptin, tumor necrosis factor-alpha and interleukins 1 and 6 are increased in patients with chronic kidney disease (CKD). In light of the increasing re...
Detailed Description
Hypothesis: The energy cost of growth is increased in experimental CKD. Caloric intake has been shown to correlate with height velocity in children with CKD, and calorie supplementation has been clear...
Eligibility Criteria
Inclusion
- Chronic renal insufficiency as defined by the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS; estimated creatinine clearance \< 75 ml/min/1.73 m2 by the Schwartz formula
- Tanner Stage I or II
- Availability of growth data for the preceding 6 months, and growth failure defined as height \< 5th percentile for chronological age, and/or SDS score for height more negative than -1.88, and/or height velocity SDS \< 0 for six months
Exclusion
- Unable or unwilling to adhere to the protocol
- Additional diagnoses that could impair responsiveness to GH, e.g. dwarfism syndromes or significant extra-renal organ disease, e.g. chronic liver disease, diabetes mellitus, AIDS
- Taking medications that influence growth
- Slipped capital femoral epiphysis or avascular necrosis of femoral head
- Constitutional short stature
- Lack of growth potential, e.g. closed epiphysis
- Steroid therapy within previous 3 months
- Known allergy or sensitivity to rhGH
- Previous exposure to a growth hormone product (the patients must be naïve to growth hormone)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00194961
End Date
December 1 2007
Last Update
March 25 2008
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10021