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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

Overview

Status
Completed
Phase
Not applicable
Enrollment
49 participants (actual)
Sponsor
University of Virginia · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Aug 2006
Primary completion
Jan 2009
Completion
May 2010
First posted
2 Nov 2006 (estimated)
Last update posted
20 Feb 2017
Conditions
Chronic Kidney Disease · End Stage Renal Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. N/A

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

    NCT00395291

    Aug 2006 to May 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The objective of this study is to determine MK-0677 increases IGF-1 in patients with end stage renal disease (ESRD) on hemodialysis.

Interventions

  • MK-0677Drug
  • PlaceboDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

Secondary outcomes(12)
  1. Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention.

    Registry description

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

  2. Change in Leptin After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  3. Change in Insulin After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  4. Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  5. Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  6. Change in CRPs After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  7. Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  8. Changes in the Following Level: IL-6

    Time frame · After the subject has comleted their last visit

    Registry description

    Change in IL-6 after 30 days of intervention.

  9. Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  10. Change in Esterase After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  11. Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

  12. Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.

    Time frame · Baseline and after 30 days of intervention

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and after 30 days of intervention

Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.

GroupValue (ng/ml)Spread
MK-067792.762.3
Placebo6.740.2
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline and after 30 days of intervention.

Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.

GroupValue (pg/ml)Spread
MK-0677-23.468.9
Placebo3.5150.3
Secondary outcomeMean· Baseline and after 30 days of intervention

Change in Leptin After 30 Days of Intervention Compared to Baseline Level.

GroupValue (ng/ml)Spread
MK-067724.450.2
Placebo-6.930.4
Secondary outcomeMean· Baseline and after 30 days of intervention

Change in Insulin After 30 Days of Intervention Compared to Baseline Level.

GroupValue (uIU/ml)Spread
MK-06773.7710.5
Placebo-.212.5
Secondary outcomeMean· Baseline and after 30 days of intervention

Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.

GroupValue (pg/ml)Spread
MK-067730.2201.5
Placebo-44.05157.4
Secondary outcomeMean· Baseline and after 30 days of intervention

Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.

GroupValue (pg/ml)Spread
MK-06771.25.9
Placebo-0.714.6
Secondary outcomeMean· Baseline and after 30 days of intervention

Change in CRPs After 30 Days of Intervention Compared to Baseline Level.

GroupValue (mg/ml)Spread
MK-06772.613.4
Placebo6.032.7
Secondary outcomeMean· Baseline and after 30 days of intervention

Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.

GroupValue (pg/ml)Spread
MK-06770.00.2
Placebo-0.00.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
MK-0677Subjects took 25mg of MK-0677 for at least 30 Days.–4 / 265 / 26
PlaceboSubjects took Placebo for at least 30 days.–3 / 260 / 26

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 99 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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) * Diabetes with one of more of the following: 1. Poorly controlled diabetes as defined by a HbA1C \> 7.0% at baseline) 2. Proliferative diabetic retinopathy \[To participate in this study, diabetic patients will need to have had a dilated ophthalmology exam within 12 months of enrollment. Individuals who already have extensive background retinopathy will need to have a dilated ophthalmology exam within the 3 months of enrollment. Patients with pre-proliferative or proliferative retinopathy will be excluded\]. 3. 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: 1. Acute coronary syndrome (e.g., myocardial infarction or unstable angina) 2. Coronary artery intervention (e.g., coronary bypass graft \[CABG\], percutaneous transluminal coronary angioplasty \[PTCA\]). 3. 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.

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