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

NCT00395291 | Completed Results DMC

• 1 other identifier: 12569
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease; End Stage Renal Disease

Keywords

Chronic kidney disease; End stage renal disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 30 days of intervention

Secondary Outcomes (12)

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

  Baseline and after 30 days of intervention.

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

  Baseline and after 30 days of intervention

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

  Baseline and after 30 days of intervention

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

  Baseline and after 30 days of intervention

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

  Baseline and after 30 days of intervention

Study Arms (2)

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.

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.

Drug: MK-0677; Drug: Placebo

Interventions

MK-0677 DRUG

The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days.

MK-0677 then Placebo; Placebo then MK-0677

Placebo DRUG

Placebo

MK-0677 then Placebo; Placebo then MK-0677

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- GFR by the MDRD estimate \< 30ml/minute/1.73m2 or on hemodialysis

You may not qualify if:

• 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:
• 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 \[PTCA\]).

Sponsors & Collaborators

• University of Virginia: lead
• National Institutes of Health (NIH): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

ibutamoren mesylate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We completed the appropriate number of subjects to get the statistical data needed. We had several screen fails (subjects that did not meet the inclusion/exclusion criteria.)

Results Point of Contact

• Title: W. Kline Bolton, MD
• Organization: University of Virginia

wkb5s@Virginia.edu

434-924-9692

Study Officials

• Warren K Bolton, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 2, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: May 1, 2010
• Last Updated: February 20, 2017
• Results First Posted: January 6, 2012

Record last verified: 2017-01

Locations

US (1)