Trial · Interventional
WithdrawnPhase 2Registry dataGrowth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: Could not obtain drug supply from manufacturer
Overview
- Status
- Withdrawn
- Phase
- Phase 2
- Enrollment
- 0 participants (actual)
- Sponsor
- University of Virginia · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Mar 2009
- Primary completion
- Apr 2010
- Completion
- Apr 2010
- First posted
- 28 Apr 2011 (estimated)
- Last update posted
- 14 May 2018
- Conditions
- Chronic Kidney Disease · Kidney Disease
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2Withdrawn
Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects
NCT01343641Mar 2009 to Apr 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- MK-0677Drug
- PlaceboDrug
Arms2
Experimental
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.
Placebo comparator
Placebo
Inactive Pill used as a comparator
Primary outcomes1
Outcomes the sponsor listed as primary.
Lean body weight.
Time frame · 12 months
Registry description
N/A - Study Withdrawn
Secondary outcomes(5)
Cytokine levels
Time frame · 12 months
Registry description
N/A - Study Withdrawn
Hormone levels
Time frame · 12 months
Registry description
N/A - Study Withdrawn
Nutritional status
Time frame · 12 months
Registry description
N/A - Study Withdrawn
Quality of life
Time frame · 12 months
Registry description
N/A - Study Withdrawn
Physical function
Time frame · 12 months
Registry description
N/A - Study Withdrawn
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.