Overview

A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis

Status:
Terminated
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
Summary
Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric intake.
Phase:
Phase 2
Details
Lead Sponsor:
QLT Inc.