Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients

This study has been completed.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

Merck

Information provided by (Responsible Party):

Warren K Bolton, University of Virginia

ClinicalTrials.gov Identifier:

NCT00395291

First received: November 1, 2006

Last updated: November 30, 2011

Last verified: November 2011

History of Changes

Results First Received: August 2, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Chronic Kidney Disease End Stage Renal Disease
Intervention:	Drug: MK-0677

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruited our subjects from 3 clinics at the University of Virginia. Our clinics were located at the Dialysis Units in Charlottesville, VA, Fisherville, VA, and Zion Crossroads, VA. Subjects were recruited into this study between March 2007 and August 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
49 Subjects were recruited; 26 Subjects started intervention (4 Subjects started study intervention and then were dropped from the study), 22 Subjects Completed this trial. 1 Subject withdrew their consent prior to study intervention. 22 Subjects did not meet inclusion/exclusion criteria.

Reporting Groups

	Description
MK-0677 First, Then Placebo	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo First, Then MK-0677	Subjects took Placebo for at least 30 days.

Participant Flow for 3 periods

Period 1: First Intervention

	MK-0677 First, Then Placebo	Placebo First, Then MK-0677
STARTED	17	9
COMPLETED	15	9
NOT COMPLETED	2	0

Period 2: Washout Period for 30 Days

	MK-0677 First, Then Placebo	Placebo First, Then MK-0677
STARTED	15	9
COMPLETED	13	9
NOT COMPLETED	2	0

Period 3: Second Intervention

	MK-0677 First, Then Placebo	Placebo First, Then MK-0677
STARTED	13	9
COMPLETED	13	9
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes groups randomized to placebo first and MK-0677 first.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	26
Age [units: participants]
<=18 years	0
Between 18 and 65 years	18
>=65 years	8
Age [units: years] Mean ± Standard Deviation	57.3 ± 14.4
Gender [units: participants]
Female	8
Male	18
Region of Enrollment [units: participants]
United States	26

Outcome Measures

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1. Primary:

Change in IGF-1 After 30 Days of Intervention [ Time Frame: After the subject has comleted their last visit ]

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2. Secondary:

Change in the Following Level: Acyl-Ghrelin [ Time Frame: After the subject has comleted their last visit ]

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3. Secondary:

Change in the Following Level: Leptin [ Time Frame: After the subject has comleted their last visit ]

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4. Secondary:

Change in the Following Level: Insulin [ Time Frame: After the subject has comleted their last visit ]

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5. Secondary:

Changes in the Following Level: Des-Acyl-Ghrelin [ Time Frame: After the subject has comleted their last visit ]

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6. Secondary:

Changes in the Following Level: TNF-alpha [ Time Frame: After the subject has comleted their last visit ]

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7. Secondary:

Changes in the Following Level: CRPs [ Time Frame: After the subject has comleted their last visit ]

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8. Secondary:

Changes in the Following Level: IL-1 [ Time Frame: After the subject has comleted their last visit ]

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9. Secondary:

Changes in the Following Level: IL-6 [ Time Frame: After the subject has comleted their last visit ]

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10. Secondary:

Changes in the Following Level: IL-10 [ Time Frame: After the subject has comleted their last visit ]

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Measure Type	Secondary
Measure Title	Changes in the Following Level: IL-10
Measure Description	Change in IL-10 after 30 days of intervention.
Time Frame	After the subject has comleted their last visit
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Reporting Groups

	Description
MK-0677	Subjects took 25mg of MK-0677 for at least 30 Days.
Placebo	Subjects took Placebo for at least 30 days.

Measured Values

	MK-0677	Placebo
Number of Participants Analyzed [units: participants]	22	21
Changes in the Following Level: IL-10 [units: pg/ml] Mean ± Standard Deviation	-0.1 ± 1.9	0.7 ± 1.7

Statistical Analysis 1 for Changes in the Following Level: IL-10

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.277

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions. Because IL-10 is considered as a secondary outcome, no power analysis was conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

11. Secondary:

Changes in the Following Level: Esterase [ Time Frame: After the subject has comleted their last visit ]

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12. Secondary:

Changes in the Following Level: Adiponectin [ Time Frame: After the subject has comleted their last visit ]

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13. Secondary:

Change in the Following Level: Total Ghrelin [ Time Frame: After the subject has comleted their last visit ]

Show Outcome Measure 13

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We completed the appropriate number of subjects to get the statistical data needed. We had several screen fails (subjects that did not meet the inclusion/exclusion criteria.)

Results Point of Contact:

Name/Title: W. Kline Bolton, MD
Organization: University of Virginia
phone: 434-924-9692
e-mail: wkb5s@Virginia.edu

No publications provided

Responsible Party:	Warren K Bolton, University of Virginia
ClinicalTrials.gov Identifier:	NCT00395291 History of Changes
Other Study ID Numbers:	12569
Study First Received:	November 1, 2006
Results First Received:	August 2, 2011
Last Updated:	November 30, 2011
Health Authority:	United States: Food and Drug Administration

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