Status:
TERMINATED
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
Lead Sponsor:
QLT Inc.
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
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 deli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00381602
Start Date
September 1 2006
End Date
May 1 2007
Last Update
April 4 2011
Active Locations (2)
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1
Tulane University Medical School
New Orleans, Louisiana, United States, 70112
2
Mayo Clinic
Rochester, Minnesota, United States, 55905