Chronic Kidney DiseasePhase 2NCT01343641
Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects
A Phase 2 study testing MK-0677 in people with Chronic Kidney Disease and Kidney Disease, run by University of Virginia at 1 site in United States.
Trial summary
This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing the following procedures: Informed consent process, followed by evaluation and screening tests to confirm patients' eligibility. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease, Kidney 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 to 85.
- GFR by the MDRD estimate ≤ 30 ml/minute/ 1.73m2 at two consecutive determinations (one GFR result from the screening visit labs and another GFR result from a prior laboratory determination and/or an unscheduled visit to confirm that the GFR is truly within the correct range.)
Who cannot join
- Prior use of experimental drug, MK-0677
- Subject has been diagnosed with neuromuscular or neurological disease causing muscle weakness.
- Body mass index greater than 35 kg/m2, or morbid obesity
- Uncontrolled hypothyroidism, defined as an elevated serum thyroid stimulating hormone (TSH) and a free serum thyroxine (T4) less than the lower limit of normal, when tested at screening (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 screening
- Hemoglobin < 10 Gm/dl at screening
Show all 31Show fewer
- Elevated serum transaminases (alanine transaminase (ALT) and aspartate transaminase (AST). (≥2.0 times the upper limit of normal at screening)
- Elevated alkaline phosphatase (Alk Phos). (≥3.0 times the upper limit of normal at screening)
- Diabetes with one or more of the following:
- Poorly controlled diabetes as defined by a HbA1C >7.0% at screening
- Pre-proliferative and Proliferative diabetic retinopathy [To participate in this study, diabetic patients will need to have had a dilated ophthalmology exam or retinal photography 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. (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 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. (a drug screen will not be done, this information will be obtained by history)
- Patient plans to relocate 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.
- If female, patient must not be pregnant or nursing. Patient must be postmenopausal, surgically sterilized, or willing to take adequate contraceptive precautions (i.e. use double barrier methods).
- 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
Official title: A Phase 2, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Determine Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Subjects With Stage 4 and Stage 5 Kidney Disease
This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing the following procedures: Informed consent process, followed by evaluation and screening tests to confirm patients' eligibility. Patients whose screening laboratory results for glycated hemoglobin level, thyroid function, or liver function exceed protocol eligibility criteria will not be randomized. Other exclusions are Congestive Heart Failure Class III or IV by the New York Heart Assocation's (NYHA) Guidelines and specified cardiovascular disorders within six months of baseline visit and muscle weakness associated with neuromuscular or neurological disorders. Before the subject begins taking the experimental drug MK-0677 or placebo, baseline assessments of subjects' hormone and cytokine levels, physical condition, body mass (determined by a DEXA scan), strength and functionality, and appetite will be obtained. In addition, quality of life assessments (SF-36) will be administered. This study's primary outcome is an increase in lean body weight. Secondary outcomes are cytokine and hormone levels, including, leptin, insulin, ghrelin, TNF- alpha, CRPs, IL-1, IL-6, and IL-10, ghrelin associated esterase and adiponectin, nutritional status, quality of life (QoL), food appreciation, physical function and economic impact. 70 subjects will be the enrollment target. This number was determined to offset projected screen failure and early withdrawal rates, and to ensure that 42 subjects complete the study.
- Conditions
- Chronic Kidney Disease, Kidney Disease
- Being tested
- MK-0677, Placebo
- Keywords
- Kidney Disease, Chronic Kidney Disease, Growth Hormone
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0677Drug
The oral agent MK-677 is spiropiperidine, Merck L-163 191, GH secretagogue ghrelin mimetic which increases GH and IGF-I secretion, fat free mass and energy expenditure76-79. It is produced by Merck \& Co, Inc.
PlaceboDrug
Inactive Pill used as a comparator
| Study group | Role | What they receive |
|---|---|---|
| MK-0677 | Experimental | The oral agent MK-677 is spiropiperidine, Merck L-163 191, GH secretagogue ghrelin mimetic which increases GH and IGF-I secretion, fat free mass and energy expenditure76-79. It is produced by Merck \& Co, Inc. Receives: Drug: MK-0677 |
| Placebo | Placebo comparator | Inactive Pill used as a comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body weight.
N/A - Study Withdrawn
Measured: 12 months
Secondary outcomes (5)
Cytokine levels
N/A - Study Withdrawn
Measured: 12 months
Hormone levels
N/A - Study Withdrawn
Measured: 12 months
Nutritional status
N/A - Study Withdrawn
Measured: 12 months
Quality of life
N/A - Study Withdrawn
Measured: 12 months
Physical function
N/A - Study Withdrawn
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Could not obtain drug supply from manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01343641
- Sponsor's protocol ID
- 13684
- Other IDs
- NIH Grant Number-R21DK077372, IND Number-54,041
- Status last verified
- Apr 2012
- First submitted
- 29 Jul 2010
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Determine Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Subjects With Stage 4 and Stage 5 Kidney Disease
- ClinicalTrials.gov ID
- NCT01343641
- Acronym / sponsor ID
- 13684
- Conditions
- Chronic Kidney Disease, Kidney Disease
- Keywords
- Kidney Disease, Chronic Kidney Disease, Growth Hormone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not obtain drug supply from manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Merck Sharp & Dohme LLC
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing the following procedures: Informed consent process, followed by evaluation and screening tests to confirm patients' eligibility. Patients whose screening laboratory results for glycated hemoglobin level, thyroid function, or liver function exceed protocol eligibility criteria will not be randomized. Other exclusions are Congestive Heart Failure Class III or IV by the New York Heart Assocation's (NYHA) Guidelines and specified cardiovascular disorders within six months of baseline visit and muscle weakness associated with neuromuscular or neurological disorders. Before the subject begins taking the experimental drug MK-0677 or placebo, baseline assessments of subjects' hormone and cytokine levels, physical condition, body mass (determined by a DEXA scan), strength and functionality, and appetite will be obtained. In addition, quality of life assessments (SF-36) will be administered. This study's primary outcome is an increase in lean body weight. Secondary outcomes are cytokine and hormone levels, including, leptin, insulin, ghrelin, TNF- alpha, CRPs, IL-1, IL-6, and IL-10, ghrelin associated esterase and adiponectin, nutritional status, quality of life (QoL), food appreciation, physical function and economic impact. 70 subjects will be the enrollment target. This number was determined to offset projected screen failure and early withdrawal rates, and to ensure that 42 subjects complete the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-0677 | Experimental | Drug: MK-0677The oral agent MK-677 is spiropiperidine, Merck L-163 191, GH secretagogue ghrelin mimetic which increases GH and IGF-I secretion, fat free mass and energy expenditure76-79. It is produced by Merck \& Co, Inc. |
| Placebo | Placebo comparator | Drug: PlaceboInactive Pill used as a comparator |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female age 18 to 85.
- GFR by the MDRD estimate ≤ 30 ml/minute/ 1.73m2 at two consecutive determinations (one GFR result from the screening visit labs and another GFR result from a prior laboratory determination and/or an unscheduled visit to confirm that the GFR is truly within the correct range.)
Key exclusion criteria (31 listed)
- Prior use of experimental drug, MK-0677
- Subject has been diagnosed with neuromuscular or neurological disease causing muscle weakness.
- Body mass index greater than 35 kg/m2, or morbid obesity
- Uncontrolled hypothyroidism, defined as an elevated serum thyroid stimulating hormone (TSH) and a free serum thyroxine (T4) less than the lower limit of normal, when tested at screening (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 screening
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 oral agent MK-677 is spiropiperidine, Merck L-163 191, GH secretagogue ghrelin mimetic which increases GH and IGF-I secretion, fat free mass and energy expenditure76-79. It is produced by Merck \& Co, Inc. | Drug | MK-0677 |
| PlaceboInactive Pill used as a comparator | Drug | Placebo |
Primary outcome
Lean body weight.
Time frame: 12 months
N/A - Study Withdrawn
5 secondary outcomes
Cytokine levels
Time frame: 12 months
Hormone levels
Time frame: 12 months
Nutritional status
Time frame: 12 months
Quality of life
Time frame: 12 months
Physical function
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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 Phase 2 study testing MK-0677 in people with Chronic Kidney Disease and Kidney 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 2 inclusion and 31 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: withdrawn, as of the sponsor's last update on 14 May 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Lean body weight. (time frame: 12 months). 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 14 May 2018.