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

NCT00194961 | Terminated Phase 4

• 1 other identifier: M2758s
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Growth Failure; Cytokines; leptin

Outcome Measures

Primary Outcomes (1)

• The primary objective will be to evaluate biochemical/metabolic, and immunologic parameters in relation to body composition.

  pre- and post-rhGH therapy

Secondary Outcomes (1)

• 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.

Interventions

Recombinant Human Growth Hormone DRUG

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Failure to Thrive

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Valerie L Johnson, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Completion: December 1, 2007
• Last Updated: March 25, 2008

Record last verified: 2008-03

Locations

US (1)