Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis

NCT00004429 | Completed

• 2 other identifiers: 199/13377VUMC-FDR000943
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: I. Assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients.

Conditions

Kidney Failure, Chronic

Keywords

end stage renal disease; rare disease; renal and genitourinary disorders

Interventions

growth hormone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * On hemodialysis or peritoneal dialysis for more than 3 months * Optimally dialyzed (urea reduction ratio greater than 65%) * Suboptimal nutritional status identified by one of the following criteria: -Protein catabolic rate less than 0.85 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months -Progressive unintentional weight loss of more than 2.5% of the initial or ideal body weight and/or patient weighs less than 90% of ideal body weight -Biochemical parameters of malnutrition defined by two or more of the following measurements over the past 3 months: Serum albumin no greater than 3.7 g/dL Serum transferrin concentration less than 250 mg/dL Serum prealbumin concentration less than 30 mg/dL Serum IGF-1 concentration less than 0.250 mg/mL --Patient Characteristics-- * No active autoimmune, inflammatory, or infectious disease At least 6 months since any documented malignancy * No unusual dietary restrictions At least 3 months since peritonitis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead
• Vanderbilt University: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2516, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Rare Diseases; Urogenital Diseases

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; 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

• Talat Alp Ikizler

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: December 1, 1999
• Study Completion: February 1, 2005
• Last Updated: March 25, 2015

Record last verified: 2007-10

Locations

US (1)