NCT01343641

Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects

A Phase 2, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Determine Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Subjects With Stage 4 and Stage 5 Kidney Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing the following procedures: Informed consent process, followed by evaluation and screening tests to confirm patients' eligibility. Patients whose screening laboratory results for glycated hemoglobin level, thyroid function, or liver function exceed protocol eligibility criteria will not be randomized. Other exclusions are Congestive Heart Failure Class III or IV by the New York Heart Assocation's (NYHA) Guidelines and specified cardiovascular disorders within six months of baseline visit and muscle weakness associated with neuromuscular or neurological disorders. Before the subject begins taking the experimental drug MK-0677 or placebo, baseline assessments of subjects' hormone and cytokine levels, physical condition, body mass (determined by a DEXA scan), strength and functionality, and appetite will be obtained. In addition, quality of life assessments (SF-36) will be administered. This study's primary outcome is an increase in lean body weight. Secondary outcomes are cytokine and hormone levels, including, leptin, insulin, ghrelin, TNF- alpha, CRPs, IL-1, IL-6, and IL-10, ghrelin associated esterase and adiponectin, nutritional status, quality of life (QoL), food appreciation, physical function and economic impact. 70 subjects will be the enrollment target. This number was determined to offset projected screen failure and early withdrawal rates, and to ensure that 42 subjects complete the study.

Conditions

• Chronic Kidney Disease
• Kidney Disease

Interventions

Type	Name	Description
DRUG	MK-0677	The oral agent MK-677 is spiropiperidine, Merck L-163 191, GH secretagogue ghrelin mimetic which increases GH and IGF-I secretion, fat free mass and energy expenditure76-79. It is produced by Merck \& Co, Inc.
DRUG	Placebo	Inactive Pill used as a comparator

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2011-04-28
• Last updated: 2018-05-14

Locations

1 site across 1 country: United States