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
Stopped early · Phase 2 · Has a placebo group
Conditions studied: End Stage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT00381602
- Run by
- QLT Inc.
- People needed
- 3
- Starts
- 2006-09-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2011-04-04
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Tulane University Medical School — New Orleans, Louisiana, United States
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.