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

FDA Office of Orphan Products Development1 site in 1 country25 target enrollmentDecember 1999

ConditionsKidney Failure, Chronic

Drugsgrowth hormone

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Failure, Chronic
Sponsor: FDA Office of Orphan Products Development
Enrollment: 25
Locations: 1
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

December 1999

End Date

February 2005

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover