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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QLT Inc.

Criteria

Inclusion Criteria:

• Subjects with ESRD who have been on HD for at least 3 months and have a urea reduction rate (URR) of at least 65%.

• Subjects who are 18 to 70 years of age.

• Subjects who have a body mass index (BMI) less than 30, albumin greater than 3.3 g/dL, and MIS of 5 to 10 (inclusive).

Exclusion Criteria:

• Subjects who have diabetes and are currently taking insulin.

• Subjects who have a history of or current significant central nervous system (CNS) disorders.

• Subjects who have active infection at baseline.

• Subjects who have active or unstable cardiac or arterial disease.

• Subjects who have uncontrolled tertiary hyperparathyroid condition.

• Subjects who have anemia.

• Subjects who have a history of hepatitis or current liver disease.