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

ClinicalTrials.gov ID: NCT00381602

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00381602
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: QLT Inc.; Industry
Enrollment: 3 participants

Conditions and interventions

Conditions

End Stage Renal Disease

Interventions

GHRP-1/AG 70 mg depot in ESRD Drug
Placebo Other

Drug · Other

Eligibility (public fields only)

Age range: 18 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2006 (Type not available)
Primary completion: May 2007 (Actual)
Completion: May 2007 (Actual)
Last update posted: Apr 4, 2011

2006 – 2007

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Tulane University Medical School	New Orleans	Louisiana	70112	—
Mayo Clinic	Rochester	Minnesota	55905	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00381602, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 4, 2011 · Synced Nov 14, 2026