A Phase 2 interventional study of GHRP-1/AG 70 mg depot in ESRD and Placebo in End Stage Renal Disease, sponsored by QLT Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-04-04.
Sponsored by QLT Inc. · Phase 2, Interventional, and Treatment
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →QLT Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Vital signs
ECG
clinical chemistry and hematology
MIS
caloric intake (protein, fat, carbohydrates, total)
nPCR
BMI and dry weight
clinical laboratory parameters
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
This study is terminated, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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QLT Inc.