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

This study has been completed.
Sponsor:
Collaborator:
Vanderbilt University
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004429
First received: October 18, 1999
Last updated: October 1, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention
Kidney Failure, Chronic
 Drug: growth hormone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Enrollment: 25
Study Start Date: December 1999
Study Completion Date: February 2005
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004429

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2516
Sponsors and Collaborators
FDA Office of Orphan Products Development
Vanderbilt University
Investigators
Study Chair: Talat Alp Ikizler Vanderbilt University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004429     History of Changes
Other Study ID Numbers: 199/13377, VUMC-FDR000943
Study First Received: October 18, 1999
Last Updated: October 1, 2007
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
end stage renal disease
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013