Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects
Status:
Withdrawn
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Virginia
Collaborators:
Merck Sharp & Dohme Corp. National Institutes of Health (NIH)