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Home > "R" Clinical Trials Conditions > Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis  Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
For Condition: Kidney Failure, Chronic
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Vanderbilt University Medical Center
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Crossover Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
TalatIkizler, Study Chair, Vanderbilt University Medical Center
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Talat Ikizler 615-343-6104
Additional Information:
Study ID Numbers: 199/13377; VUMC-FDR000943
Study Start Date: December 1999
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004429
Other Kidney Failure, Chronic Studies:
1. Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
2. Genetic Analysis of Human Hypertensive End Stage Renal Disease (H-ESRD)
3. Study to evaluate the effectiveness of StaphVAX in adults on hemodialysis
4. Patient-Provider Trust Among Individuals with End-Stage Kidney Disease
5. Comparison of daily nocturnal hemodialysis with daily hemodialysis
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Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
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