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

This study has been completed.

First Received: October 18, 1999 Last Updated: October 1, 2007 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Vanderbilt University
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004429

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

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment

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

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

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Rare Diseases
Kidney Failure, Chronic
Kidney Diseases
Hormones
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Kidney Failure, Chronic
Kidney Diseases
Hormones
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009