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

End Stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00381602
• Other study ID #: GHRP ESRD 01
• Status: Terminated
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: March 25, 2011
• Start date: September 2006
• Est. completion date: May 2007

Study information

• Verified date: March 2011
• Source: QLT Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• GHRP-1/AG 70 mg depot in ESRD

Other:
• Placebo

Locations

Country	Name	City	State
United States	Tulane University Medical School	New Orleans	Louisiana
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
QLT Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs
Primary	ECG
Primary	clinical chemistry and hematology
Primary	MIS
Primary	caloric intake (protein, fat, carbohydrates, total)
Primary	nPCR
Primary	BMI and dry weight
Primary	clinical laboratory parameters
Secondary	IGF-1, IGF-BP3, GH, prolactin, and cortisol plasma concentrations
Secondary	GHRP-1 and des-Ala-GHRP-1 plasma concentrations
Secondary	adverse events
Secondary	concomitant medications
Secondary	endocrine parameters