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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- QLT Inc.
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Vital signs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Vital signs
ECG
clinical chemistry and hematology
MIS
caloric intake (protein, fat, carbohydrates, total)
nPCR
BMI and dry weight
clinical laboratory parameters
次要结局
- 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