Effect of Growth Hormone on Leptin, Cytokines and Body Composition of Children With Growth Failure Due to Chronic Kidney Disease

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 recognition that growth hormone receptor signaling involves cytokine pathway activation, the investigators hypothesize that maladaptation of cytokine regulation in chronic kidney disease may underlie growth failure. Secondly, they hypothesize that administration of recombinant human growth hormone (rhGH) will result in growth rate stimulation in pre-pubertal children with growth impairment due to chronic kidney disease by down regulation of the cytokine pathways.

This is a non-randomized open-label study to evaluate the effect of recombinant human growth hormone on biochemical/metabolic and immunologic parameters in relation to body composition pre- and post-recombinant human growth hormone therapy of pre-pubertal growth hormone naive children. The efficacy of recombinant human growth hormone to improve growth velocity in pre-pubertal children with growth failure is a secondary objective. Fifteen children are to be studied over a six month period. Each patient will serve as his/her own control. Six months of growth data prior to study is required.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Genentech, Inc.
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)