End Stage Renal Disease
Conditions
Keywords
End stage renal disease, Hemodialysis, Malnutrition, End stage renal disease (ESRD)
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 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.
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 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.
Interventions
DRUGGHRP-1/AG 70 mg depot in ESRD
OTHERPlacebo
Sponsors
QLT Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI and dry weight | — |
| clinical laboratory parameters | — |
| nPCR | — |
| Vital signs | — |
| ECG | — |
| clinical chemistry and hematology | — |
| MIS | — |
| caloric intake (protein, fat, carbohydrates, total) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed