Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects
Public ClinicalTrials.gov record NCT01343641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01343641
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2009
- Primary completion
- Mar 31, 2010
- Completion
- Mar 31, 2010
- Last update posted
- May 13, 2018
2009 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01343641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2018 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01343641 live on ClinicalTrials.gov.