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.

Condition	Treatment or Intervention
Kidney Failure, Chronic	Drug: growth hormone

PROTOCOL OUTLINE: This is a randomized, double blind, placebo-controlled, cross-over study. Prior to randomization each patient's protein and calorie intake is assessed and optimized as possible. Patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months. At the end of this 6 month period, patients undergo a 4 week washout period. After the washout period, patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting

Study chairs or principal investigators

Talat Alp Ikizler,  Study Chair,  Vanderbilt University Medical Center   

Study ID Numbers:  199/13377; VUMC-FDR000943
Record last reviewed:  January 2000
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004429
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09