Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients
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ClinicalTrials.gov Identifier: NCT00395291 |
Recruitment Status
:
Completed
First Posted
: November 2, 2006
Results First Posted
: January 6, 2012
Last Update Posted
: February 20, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease End Stage Renal Disease | Drug: MK-0677 Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | May 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: MK-0677 then Placebo
MK-0677 and Placebo - All subjects were given MK-0677 for a 30 +/- 7 days and then they were given a placebo for 30 +/- 7 days.
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Drug: MK-0677
The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days.
Drug: Placebo
Placebo
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Experimental: Placebo then MK-0677
MK-0677 and Placebo - All subjects were given Placebo for a 30 +/- 7 days and then they were given MK-0677 for 30 +/- 7 days.
|
Drug: MK-0677
The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days.
Drug: Placebo
Placebo
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- Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in Leptin After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in Insulin After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in CRPs After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in IL-1 After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Changes in the Following Level: IL-6 [ Time Frame: After the subject has comleted their last visit ]Change in IL-6 after 30 days of intervention.
- Change in IL-10 After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: 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.
- Change in Esterase After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: Baseline and after 30 days of intervention ]Looking for a change in the Esterase levels after the subject has been on intervention for 30 days compared to baseline levels.
- Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: Baseline and after 30 days of intervention ]Looking for a change in the Adiponectin levels after the subject has been on intervention for 30 days compared to baseline levels.
- Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level. [ Time Frame: Baseline and after 30 days of intervention ]Looking for a change in the Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- GFR by the MDRD estimate < 30ml/minute/1.73m2 or on hemodialysis
Exclusion Criteria:
- Body mass index greater than 35 kg/m2, or morbid obesity
- Uncontrolled hypothyroidism, defined as an elevated serum thyroid stimulating hormone (THS) and a free serum thyroxine (T4) less than the lower limit of normal, when tested at baseline (Patients requiring thyroid replacement during the study may continue.)
- Uncontrolled hyperthyroidism, defined as a TSH less than the lower limit of normal and an elevated free T4, when tested at baseline
- Hemoglobin <10 Gm/dl
- Elevated serum transaminases (>2.0 times the upper limit of normal at baseline)
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Diabetes with one of more of the following:
- Poorly controlled diabetes as defined by a HbA1C > 7.0% at baseline)
- Proliferative diabetic retinopathy [To participate in this study, diabetic patients will need to have had a dilated ophthalmology exam within 12 months of enrollment. Individuals who already have extensive background retinopathy will need to have a dilated ophthalmology exam within the 3 months of enrollment. Patients with pre-proliferative or proliferative retinopathy will be excluded].
- Unwilling or unable to check blood glucose at home at least daily.
- Currently receiving a systemic corticosteroid dose of >10 mg prednisone (or equivalent), or patient has received, for a duration > 30 days in the previous 6 months (i.e., prior to signing the informed consent form), a systemic corticosteroid dose of > 10 mg prednisone (or equivalent). (The previous use, or current use, of a topical or inhaled corticosteroid is allowed.)
- Currently taking or previously on an anabolic steroid or growth hormone at any dose, or for any duration, during the 12 months prior to study entry.
- Significant end-organ disease, other than kidney disease, which, in the opinion of the investigator may pose an added risk to the patient, confound the study results, or impair the patient's ability to complete the trial.
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Any of the following disorders within 6 months prior to baseline:
- Acute coronary syndrome (e.g., myocardial infarction or unstable angina)
- Coronary artery intervention (e.g., coronary bypass graft [CABG], percutaneous transluminal coronary angioplasty [PTCA]).
- Stroke or transient ischemic neurological disorder (e.g. transient ischemic attack [TIA])
- New or worsening signs or symptoms of coronary heart disease within the 3 months prior to baseline.
- NYHA (New York Heart Association)Class III or IV congestive heart failure (definitions shown in Appendix A)
- Uncontrolled hypertension when checked at screening visit: as evidenced by > 160 systolic and/or 100 diastolic (measured in dominant or non-dialysis access arm, after at least 5 minutes, sitting)
- Cancer, or diagnosis of malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or adequately treated in situ cervical cancer.
- Active carpal tunnel syndrome
- Patient is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or such that adherence to the study procedures and dosing regimens is questionable.
- Patient is, at study entry, a regular user (including "recreational use") of illicit drugs or had a recent history (within the last 5 years) of drug or alcohol abuse.
- Patient plans to relocate or change to a different dialysis center during the study, rendering follow-up per protocol, impractical.
- Patient is participating in, or has participated in, another study with an investigational drug within 30 days prior to signing the informed consent form.
- Women who are pregnant or lactating
- HIV positive (medical history review and patient report)
- Patient is on potent CYP3A4 Inhibitor or Inducer Drugs within one week of starting study drug.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395291
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Warren K Bolton, MD | University of Virginia |
Responsible Party: | Warren K Bolton, Principal Investigator, University of Virginia |
ClinicalTrials.gov Identifier: | NCT00395291 History of Changes |
Other Study ID Numbers: |
12569 |
First Posted: | November 2, 2006 Key Record Dates |
Results First Posted: | January 6, 2012 |
Last Update Posted: | February 20, 2017 |
Last Verified: | January 2017 |
Keywords provided by Warren K Bolton, University of Virginia:
Chronic kidney disease End stage renal disease |
Additional relevant MeSH terms:
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases |
Renal Insufficiency Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |