Trial Outcomes & Findings for Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients (NCT NCT00395291)

NCT ID: NCT00395291

Last Updated: 2017-02-20

Results Overview

Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: Baseline and after 30 days of intervention
• Results posted on: 2017-02-20

Participant Flow

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.

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.

Participant milestones

Measure	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.
First Intervention STARTED	17	9
First Intervention COMPLETED	15	9
First Intervention NOT COMPLETED	2	0
Washout Period for 30 Days STARTED	15	9
Washout Period for 30 Days COMPLETED	13	9
Washout Period for 30 Days NOT COMPLETED	2	0
Second Intervention STARTED	13	9
Second Intervention COMPLETED	13	9
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Entire Study Population n=26 Participants Includes groups randomized to placebo first and MK-0677 first.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 14.4 • n=5 Participants
Gender Female	8 Participants n=5 Participants
Gender Male	18 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 Subjects completed both interventions and lab results were available.

Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.	92.7 ng/ml Standard Deviation 62.3	6.7 ng/ml Standard Deviation 40.2

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention.

Population: 22 subjects completed both interventions.

Looking for a change in the Acyl-Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.	-23.4 pg/ml Standard Deviation 68.9	3.5 pg/ml Standard Deviation 150.3

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects completed both interventions.

Looking for a change in the Leptin levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in Leptin After 30 Days of Intervention Compared to Baseline Level.	24.4 ng/ml Standard Deviation 50.2	-6.9 ng/ml Standard Deviation 30.4

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects completed both interventions.

Looking for a change in the Insulin levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in Insulin After 30 Days of Intervention Compared to Baseline Level.	3.77 uIU/ml Standard Deviation 10.5	-.2 uIU/ml Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 Subjects completed both interventions.

Looking for a change in the Des-Acyl Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.	30.2 pg/ml Standard Deviation 201.5	-44.05 pg/ml Standard Deviation 157.4

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Looking for a change in the TNF-alpha levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=21 Participants Subjects took Placebo for at least 30 days.
Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.	1.2 pg/ml Standard Deviation 5.9	-0.7 pg/ml Standard Deviation 14.6

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 Subjects completed both interventions.

Looking for a change in the CRPs levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in CRPs After 30 Days of Intervention Compared to Baseline Level.	2.6 mg/ml Standard Deviation 13.4	6.0 mg/ml Standard Deviation 32.7

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Looking for a change in the IL-1 levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=21 Participants Subjects took Placebo for at least 30 days.
Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.	0.0 pg/ml Standard Deviation 0.2	-0.0 pg/ml Standard Deviation 0.3

SECONDARY outcome

Timeframe: After the subject has comleted their last visit

Population: 22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Change in IL-6 after 30 days of intervention.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=21 Participants Subjects took Placebo for at least 30 days.
Changes in the Following Level: IL-6	3.1 pg/mL Standard Deviation 5.2	0.8 pg/mL Standard Deviation 6.9

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Looking for a change in the IL-10 levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=21 Participants Subjects took Placebo for at least 30 days.
Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.	-0.1 pg/ml Standard Deviation 1.9	0.7 pg/ml Standard Deviation 1.7

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects completed both interventions and results were available.

Looking for a change in the Esterase levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in Esterase After 30 Days of Intervention Compared to Baseline Level.	-1.6 units/ml Standard Deviation 10.3	-1.3 units/ml Standard Deviation 12.6

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.

Looking for a change in the Adiponectin levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=21 Participants Subjects took Placebo for at least 30 days.
Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.	1242.0 ng/ml Standard Deviation 7858.1	735.1 ng/ml Standard Deviation 4485.0

SECONDARY outcome

Timeframe: Baseline and after 30 days of intervention

Population: 22 subjects completed both interventions and lab results were available for all 22.

Looking for a change in the Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.

Outcome measures

Measure	MK-0677 n=22 Participants Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=22 Participants Subjects took Placebo for at least 30 days.
Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.	6.9 pg/ml Standard Deviation 162.5	-40.5 pg/ml Standard Deviation 192.5

Adverse Events

MK-0677

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK-0677 n=26 participants at risk Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=26 participants at risk Subjects took Placebo for at least 30 days.
Renal and urinary disorders Renal Failure	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Cardiac disorders Cardiomyopathy	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Gastrointestinal disorders Ischemic Colitis	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Surgical and medical procedures Eroded Arteriovenous Dialysis Graft	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Infections and infestations Perm-A-Cath Line Infection	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Cardiac disorders Congestive Heart Failure	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Cardiac disorders Hyperkalemia	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Blood and lymphatic system disorders Supratherapeutic INR	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	3.8% 1/26 • Number of events 1 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.

Other adverse events

Measure	MK-0677 n=26 participants at risk Subjects took 25mg of MK-0677 for at least 30 Days.	Placebo n=26 participants at risk Subjects took Placebo for at least 30 days.
Respiratory, thoracic and mediastinal disorders Cold, Cough, Sinus Congestion	11.5% 3/26 • Number of events 4 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.
Gastrointestinal disorders Nausea, Upset Stomach	7.7% 2/26 • Number of events 2 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.	0.00% 0/26 • Adverse Events were collect from the time the subject started the first intervention and ended two weeks from the last study visit.

Additional Information

W. Kline Bolton, MD

University of Virginia

Phone: 434-924-9692

Email: wkb5s@Virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place