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

NCT ID: NCT00381602

Last Updated: 2011-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-05-31

Brief 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.

Detailed Description

This is a randomized, cross-over, double-blind, vehicle-controlled study. Subjects will receive single subcutaneous injections of the active GHRP-1/AG study treatment and vehicle control (ATRIGEL delivery system) in a randomized sequence. Each injection will be followed by a 4-week period of treatment exposure and a 2-week period of washout/follow-up. Treatments will be administered on the 2nd dialysis day of a 3x/week dialysis schedule. The total duration of study participation will be 12 weeks. Safety will be followed throughtout the study with vital signs, electrocardiogram, clinical chemistry and hematology parameters, endocrine parameters, adverse events, and concomitant medications. PD effects of GHRP-1/AG will be evaluated by measuring GH, ICF-1, IGF-BP3, prolactin, and cortisol. Efficacy will be evaluated throughout the study with MIS, caloric intake, nPCR, dry weight, BMI, and albumin, BUN, creatinine, calcium, potassium, HGB, HCT, and CBC.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

GHRP-1/AG 70 mg depot in ESRD

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QLT Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Graeme R Boniface

Role: STUDY_DIRECTOR

QLT Inc.

Locations

Tulane University Medical School

New Orleans, Louisiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

GHRP ESRD 01

Identifier Type: -

Identifier Source: org_study_id