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Sponsors and Collaborators: |
University of Virginia National Institutes of Health (NIH) Merck and Company |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00395291 |
The objective of this study is to determine MK-677 increases IGF-1 in patients with stage 4/5 chronic kidney disease (CKD)and/or in patients with end stage renal disease (ESRD) on hemodialysis.
Condition | Intervention |
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Chronic Kidney Disease End Stage Renal Disease |
Drug: MK-677 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Growth Hormone Secretagogue MK-677 Therapy Effect on IGF-1 Levels in CKD and ESRD Patients |
Estimated Enrollment: | 52 |
Study Start Date: | August 2006 |
With development and progression of chronic kidney disease (CKD) to end stage renal disease (ESRD), malnutrition becomes an increasingly severe problem.
This is thought to occur from two mechanisms: decreased appetite secondary to uremia and development of a catabolic inflammatory milieu. Patients experience decreased muscle mass and functional activity associated with increased morbidity and mortality. Many therapies to improve poor nutritional state have been used with little success. Growth hormone (GH) and insulin like growth hormone (IGF-1) improve muscle mass, quality of life, nutritional parameters, immune and physical functions but must be given parenterally and are limited by expense and patient compliance. Recently, the endogenous GH receptor secretagogue (GHRS) ghrelin has been shown to raise endogenous GH and improve food intake but must be given parenterally and is not available.
The experimental drug MK-677, a synthetic GHRS, ghrelin mimetic, which is given orally, has recently been shown to increase IGF-1 and muscle mass in the elderly. Its effects in CKD and ESRD are unknown. We will study the effects of MK-677 on renal patients. Specifically, we hope to show that the drug increases IGF-1 in renal patients, and has similar effects to exogenous GH and IGF-1. Subjects will have CKD stage 4/5 or be ESRD hemodialysis patients.
This protocol is an investigator-initiated, randomized, double-blind crossover, placebo-controlled pilot study. The study's primary outcome is IGF-1 levels for subjects. Secondary outcomes will be levels of cytokines, leptin, insulin, ghrelin, TNF-alpha, CRPs, IL-1, IL-6 and IL-10.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Diabetes with one of more of the following:
Any of the following disorders within 6 months prior to baseline:
Contact: Lori Ratliff, RN | 434-924-1572 | lbr@virginia.edu |
Contact: Warren K Bolton, MD | 434-982-3577 | wkb5s@virginia.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Principal Investigator: Warren K Bolton, MD |
Principal Investigator: | Warren K Bolton, MD | University of Virginia |
Study ID Numbers: | 12569 |
Study First Received: | November 1, 2006 |
Last Updated: | November 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00395291 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic kidney disease End stage renal disease |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Kidney Diseases Hormones Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |