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

This study has been terminated.
(Funding was not approved)
Sponsor:
Collaborator:
Genentech
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194961
First received: September 12, 2005
Last updated: March 24, 2008
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Drug: Recombinant Human Growth Hormone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Study of the Effect of Recombinant Human Growth Hormone on Leptin and Cytokines in Relation to Body Composition in Pediatric Patients With Growth Failure Due to Chronic Kidney Disease (CKD)

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The primary objective will be to evaluate biochemical/metabolic, and immunologic parameters in relation to body composition. [ Time Frame: pre- and post-rhGH therapy ]

Secondary Outcome Measures:
  • The secondary objective is to examine the efficacy of rhGH to improve growth velocity in prepubertal, rhGH naïve, children with growth failure secondary to CKD.

Estimated Enrollment: 15
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194961

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Genentech
Investigators
Principal Investigator: Valerie L Johnson, MD, PhD Weill Medical College of Cornell University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00194961     History of Changes
Other Study ID Numbers: M2758s, M2758s
Study First Received: September 12, 2005
Last Updated: March 24, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Chronic Kidney Disease
Growth Failure
Cytokines
leptin

Additional relevant MeSH terms:
Failure to Thrive
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Growth Disorders
Pathologic Processes
 Urologic Diseases
Renal Insufficiency
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013