Effect of Cytokines on Growth of Children With Chronic Kidney Failure

NCT00194883 | Suspended Phase 4

• 1 other identifier: 0596-363
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Renal Insufficiency

Keywords

Recombinant Human Growth Hormone; Leptin; Cytokines; Chronic Renal Insufficiency; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Recombinant Human Growth Hormone DRUG

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

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, significant extra-renal organ disease, e.g. chronic liver disease, or chronic corticosteroid therapy

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

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

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, M.D., Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 1997
• Study Completion: May 1, 2003
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

US (1)