Effect of Cytokines on Growth of Children With Chronic Kidney Failure

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Genentech
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194883
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Children with chronic kidney failure often do not grow well. This study examines the possible causes of growth failure in these children and the response to recombinant human growth hormone. The growth hormone-insulin-like growth factor axis will be studied in relation to biochemical and immunological parameters as well as body compositional changes pre- and post recombinant human growth hormone therapy.


Condition Intervention Phase
Chronic Renal Insufficiency
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: Diagnostic
Official Title: Cytokines and Growth in Children With CRI and ESRD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To examine the efficacy of recombinant human growth hormone in improving growth velocity in prepubertal children with growth failure secondary to chronic kidney disease.

Secondary Outcome Measures:
  • To examine how recombinant human growth hormone effects body composition, the GH-IGF axis proteins and biochemical/immunological parameters in children with growth failure secondary to chronic kidney disease

Estimated Enrollment: 50
Study Start Date: April 1997
Estimated Study Completion Date: May 2003
Detailed Description:

Children with chronic renal failure (CRF; estimated creatinine clearance less than 75ml/min/1.73 m2) and end-stage renal disease (ESRD; dialysis dependent) have marked growth retardation and often do not achieve their expected height based on genetic potential despite adequate caloric supplementation, and more recently, rhGH treatment. Resistance to both endogenous and rhGH has been proposed to account for much of this growth failure, although the specific mechanisms remain unknown. Possibilities include insensitivity to GH and an inappropriate production of IGF-I and/or a reduced bioavailability secondary to an altered GH-IGF axis. Abnormalities in the GH/IGF-I axis may result in an inability of the growth plate chondrocyte to respond appropriately. Studies combining data on nutritional parameters, changes in body composition and bone density, bone turnover and the GH-IGF axis-related proteins in children with CRF and ESRD are lacking. We propose to further characterize the specific mechanisms underlying impaired growth in pre-pubertal and pubertal children with CRF or ESRD and growth failure prior to and after the initiation of rhGH therapy. The Specific Aims of this proposal are designed to allow a more efficacious use of rhGH in maximizing growth in these children. In this study measurements of total body composition, i.e., lean body mass, fat mass and bone mineral content will be made using dual photon X-ray absorptiometry. Bone mineral density will also be determined. These studies will be correlated with anthropometric, biochemical and nutritional assessments of patients before and during rhGH treatment. Letin and cytokines will be concomitantly measured. Bone collagen turnover will be quantitated using pyridinoline and deoxypyridinoline cross-links excretion (in CRF patients) and serum levels of collagen type I C-terminal propeptide (CICP) concomitant with the above measurements. Bone turnover will be further assessed by looking at additional biochemical markers of bone metabolism such as osteocalcin and bone alkaline phosphatase. Serum levels of IGF-I, IGF-II, intact and fragmented IGFBP-1, -2,-3, and GH and GH-binding activity will be determined before and during rhGH therapy and correlated to measurements made in the other studies. These studies will help elucidate the differences in rhGH responsiveness in this population. Taken together, the above studies will substantially advance our understanding of how rhGH improves growth in children with CRF and ESRD.

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current height < 2SD (or < 3rd percentile) for chronological age
  • Chronic renal failure (estimated creatinine clearance <75 mL/min/1.73m2) or ESRD (as defined by receiving maintenance HD or PD)
  • Age < 21 years and /or growth potential demonstrable by bone age

Exclusion Criteria:

  • Unable or unwilling to adhere to the protocol
  • Additional diagnoses that could impair responsiveness to GH, e.g. dwarfism syndromes, significant extra-renal organ disease, e.g. chronic liver disease, or chronic corticosteroid therapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00194883

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, M.D., Ph.D. Weill Medical College of Cornell University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00194883     History of Changes
Other Study ID Numbers: 0596-363
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
Recombinant Human Growth Hormone
Leptin
Cytokines
Chronic Renal Insufficiency
Children

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

ClinicalTrials.gov processed this record on September 18, 2014