Kidney Failure, Chronic Clinical Trial
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
FDA Office of Orphan Products Development | Vanderbilt University |
United States,
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