Clinical trial NCT00381602: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: End stage renal disease
Hemodialysis
Malnutrition
End stage renal disease (ESRD)
Lead sponsor: QLT Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vital signs
measure: ECG
measure: clinical chemistry and hematology
measure: MIS
measure: caloric intake (protein, fat, carbohydrates, total)
measure: nPCR
measure: BMI and dry weight
measure: clinical laboratory parameters
Secondary outcomes:
measure: IGF-1, IGF-BP3, GH, prolactin, and cortisol plasma concentrations
measure: GHRP-1 and des-Ala-GHRP-1 plasma concentrations
measure: adverse events
measure: concomitant medications
measure: endocrine parameters
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Medical School
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: QLT Inc.
name: Graeme R Boniface
role: STUDY_DIRECTOR
References: