Trial · NCT00395291

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

NCT00395291, Not applicable, Completed, University of Virginia; results first posted 2012-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients. Trials, record NCT00395291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00395291

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients
NCT number: NCT00395291
Status: Completed
Phases: Not applicable
Enrollment: 49 participants, actual
Lead sponsor: University of Virginia
Conditions: Chronic Kidney Disease, End Stage Renal Disease
Interventions: MK-0677, Placebo
First posted: 2006-11-02
Last updated: 2017-02-20
Results first posted: 2012-01-06
Limitations and caveats: 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.)

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention.	Looking for a change in the Acyl-Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Change in Leptin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the Leptin levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Change in Insulin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the Insulin levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the Des-Acyl Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the TNF-alpha levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Change in CRPs After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the CRPs levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the IL-1 levels after the subject has been on intervention for 30 days compared to baseline levels.
Secondary	Changes in the Following Level: IL-6	After the subject has comleted their last visit	Change in IL-6 after 30 days of intervention.
Secondary	Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	Looking for a change in the IL-10 levels after the subject has been on intervention for 30 days compared to baseline levels.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 Subjects completed both interventions and lab results were available.	ng/ml	MEAN
SECONDARY	Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention.	22 subjects completed both interventions.	pg/ml	MEAN
SECONDARY	Change in Leptin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 subjects completed both interventions.	ng/ml	MEAN
SECONDARY	Change in Insulin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 subjects completed both interventions.	uIU/ml	MEAN
SECONDARY	Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 Subjects completed both interventions.	pg/ml	MEAN
SECONDARY	Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.	pg/ml	MEAN
SECONDARY	Change in CRPs After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 Subjects completed both interventions.	mg/ml	MEAN
SECONDARY	Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.	pg/ml	MEAN
SECONDARY	Changes in the Following Level: IL-6	After the subject has comleted their last visit	22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.	pg/mL	MEAN
SECONDARY	Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.	Baseline and after 30 days of intervention	22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.	pg/ml	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.	MK-0677	92.7	Standard Deviation 62.3	ng/ml
Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.	Placebo	6.7	Standard Deviation 40.2	ng/ml
Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.	MK-0677	-23.4	Standard Deviation 68.9	pg/ml
Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.	Placebo	3.5	Standard Deviation 150.3	pg/ml
Change in Leptin After 30 Days of Intervention Compared to Baseline Level.	MK-0677	24.4	Standard Deviation 50.2	ng/ml
Change in Leptin After 30 Days of Intervention Compared to Baseline Level.	Placebo	-6.9	Standard Deviation 30.4	ng/ml
Change in Insulin After 30 Days of Intervention Compared to Baseline Level.	MK-0677	3.77	Standard Deviation 10.5	uIU/ml
Change in Insulin After 30 Days of Intervention Compared to Baseline Level.	Placebo	-.2	Standard Deviation 12.5	uIU/ml
Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.	MK-0677	30.2	Standard Deviation 201.5	pg/ml
Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.	Placebo	-44.05	Standard Deviation 157.4	pg/ml

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	MK-0677 First, Then Placebo	17
First Intervention	STARTED	Placebo First, Then MK-0677	9
First Intervention	COMPLETED	MK-0677 First, Then Placebo	15
First Intervention	COMPLETED	Placebo First, Then MK-0677	9
First Intervention	NOT COMPLETED	MK-0677 First, Then Placebo	2
First Intervention	NOT COMPLETED	Placebo First, Then MK-0677	0
Washout Period for 30 Days	STARTED	MK-0677 First, Then Placebo	15
Washout Period for 30 Days	STARTED	Placebo First, Then MK-0677	9
Washout Period for 30 Days	COMPLETED	MK-0677 First, Then Placebo	13
Washout Period for 30 Days	COMPLETED	Placebo First, Then MK-0677	9

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cold, Cough, Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MK-0677	3	26	4
other	Cold, Cough, Sinus Congestion	Respiratory, thoracic and mediastinal disorders	Placebo	0	26	0
other	Nausea, Upset Stomach	Gastrointestinal disorders	MK-0677	2	26	2
other	Nausea, Upset Stomach	Gastrointestinal disorders	Placebo	0	26	0
serious	Renal Failure	Renal and urinary disorders	MK-0677	1	26	1
serious	Renal Failure	Renal and urinary disorders	Placebo	0	26	0
serious	Cardiomyopathy	Cardiac disorders	MK-0677	0	26	0
serious	Cardiomyopathy	Cardiac disorders	Placebo	1	26	1
serious	Ischemic Colitis	Gastrointestinal disorders	MK-0677	1	26	1
serious	Ischemic Colitis	Gastrointestinal disorders	Placebo	0	26	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MK-0677
Total, all-cause mortality	Placebo
Total, other adverse events	MK-0677	5	26
Total, other adverse events	Placebo	0	26
Total, serious adverse events	MK-0677	4	26
Total, serious adverse events	Placebo	3	26

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
MK-0677 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00395291

GET https://conductscience.org/api/trials/v1/NCT00395291/results?page=2

API reference For AI assistants