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

NCT00381602 | Terminated Phase 2

• 1 other identifier: GHRP ESRD 01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease

Keywords

End stage renal disease; Hemodialysis; Malnutrition; End stage renal disease (ESRD)

Outcome Measures

Primary Outcomes (8)

• Vital signs

• ECG

• clinical chemistry and hematology

• MIS

• caloric intake (protein, fat, carbohydrates, total)

• nPCR

• BMI and dry weight

• clinical laboratory parameters

Secondary Outcomes (5)

• 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

Interventions

GHRP-1/AG 70 mg depot in ESRD DRUG

Placebo OTHER

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• QLT Inc.: lead

Study Sites (2)

Tulane University Medical School

New Orleans, Louisiana, 70112, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Malnutrition

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Graeme R Boniface

  QLT Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: April 4, 2011

Record last verified: 2011-03

Locations

US (2)