Chronic Kidney DiseaseNCT00395291
Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients
A study testing MK-0677 in people with Chronic Kidney Disease and End Stage Renal Disease, run by University of Virginia at 1 site in United States.
Trial summary
The objective of this study is to determine MK-0677 increases IGF-1 in patients with end stage renal disease (ESRD) on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease
- What is being tested?
- MK-0677
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GFR by the MDRD estimate < 30ml/minute/1.73m2 or on hemodialysis
Who cannot join
- 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)
- Diabetes with one of more of the following:
Show all 28Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The objective of this study is to determine MK-0677 increases IGF-1 in patients with end stage renal disease (ESRD) on hemodialysis.
Read the detailed description
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-0677, 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-0677 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 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, esterase, leptin, insulin, ghrelin, TNF-alpha, CRPs, IL-1, IL-6, IL-10, and adiponectin.
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Being tested
- MK-0677, Placebo
- Keywords
- Chronic kidney disease, End stage renal disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0677Drug
The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MK-0677 then Placebo | Experimental | 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. Receives: Drug: MK-0677; Drug: Placebo |
| Placebo then MK-0677 | Experimental | 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. Receives: Drug: MK-0677; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Secondary outcomes (12)
Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the Acyl-Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention.
Change in Leptin After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the Leptin levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in Insulin After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the Insulin levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the Des-Acyl Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the TNF-alpha levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in CRPs After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the CRPs levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the IL-1 levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Changes in the Following Level: IL-6
Change in IL-6 after 30 days of intervention.
Measured: After the subject has comleted their last visit
Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the IL-10 levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in Esterase After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the Esterase levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the Adiponectin levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.
Looking for a change in the Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.
Measured: Baseline and after 30 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Warren K Bolton, University of Virginia
- Investigators
- Warren K Bolton, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395291
- Sponsor's protocol ID
- 12569
- Status last verified
- Jan 2017
- First submitted
- 1 Nov 2006
- Last updated
- 20 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients
- ClinicalTrials.gov ID
- NCT00395291
- Acronym / sponsor ID
- 12569
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Keywords
- Chronic kidney disease, End stage renal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Merck Sharp & Dohme LLC
- Study start
- Aug 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Posted 6 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine MK-0677 increases IGF-1 in patients with end stage renal disease (ESRD) on hemodialysis.
Detailed description
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-0677, 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-0677 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 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, esterase, leptin, insulin, ghrelin, TNF-alpha, CRPs, IL-1, IL-6, IL-10, and adiponectin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-0677 then Placebo | Experimental | Drug: MK-0677, Drug: PlaceboMK-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. |
| Placebo then MK-0677 | Experimental | Drug: MK-0677, Drug: PlaceboMK-0677 and Placebo - All subjects were given Placebo for a 30 +/- 7 days and then they were given MK-0677 for 30 +/- 7 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GFR by the MDRD estimate < 30ml/minute/1.73m2 or on hemodialysis
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-0677The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days. | Drug | MK-0677 then Placebo, Placebo then MK-0677 |
| PlaceboPlacebo | Drug | MK-0677 then Placebo, Placebo then MK-0677 |
Primary outcome
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.
12 secondary outcomes
Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention.
Change in Leptin After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in Insulin After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in CRPs After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Changes in the Following Level: IL-6
Time frame: After the subject has comleted their last visit
Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in Esterase After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.
Time frame: Baseline and after 30 days of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren K Bolton, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MK-0677 in people with Chronic Kidney Disease and End Stage Renal Disease, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level. (time frame: Baseline and after 30 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.