| Trial ID: | L1019 |
| Source ID: | NCT00381602
|
| Associated Drug: |
Ghrp-1/Ag 70 Mg Depot In Esrd
|
| Title: |
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
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: GHRP-1/AG 70 mg depot in ESRD|OTHER: Placebo
|
| Outcome Measures: |
Primary: Vital signs|ECG|clinical chemistry and hematology|MIS|caloric intake (protein, fat, carbohydrates, total)|nPCR|BMI and dry weight|clinical laboratory parameters | Secondary: IGF-1, IGF-BP3, GH, prolactin, and cortisol plasma concentrations|GHRP-1 and des-Ala-GHRP-1 plasma concentrations|adverse events|concomitant medications|endocrine parameters
|
| Sponsor/Collaborators: |
Sponsor: QLT Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
3
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2007-05
|
| Results First Posted: |
|
| Last Update Posted: |
2011-04-04
|
| Locations: |
Tulane University Medical School, New Orleans, Louisiana, 70112, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00381602
|
