Body mass index ≥35 or morbid obesity
Uncontrolled hyperthyroidism, defined as a Thyroid Stimulating Hormone (TSH) less than the lower limit of normal and an elevated free T4 when tested at screening
Hemoglobin ≤10 g/dL
Elevated serum transaminases (≥2 times the upper limit of normal at screening)
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Diabetes with one or more of the following:
○ Poorly controlled diabetes as defined by a hemoglobin A1C > 7.0% at screening
○ Proliferative diabetic retinopathy. (To participate in this study, diabetic patients were required to have had a dilated ophthalmology exam within 12 months of enrollment. Individuals who already had extensive background retinopathy had to have a dilated ophthalmology examination with 3 months of enrollment. Patients with preproliferative or proliferative retinopathy were excluded.)
○ Unwilling or unable to check blood glucose at home at least daily
Currently receiving a systemic corticosteroid dose ≥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 ≥10 mg prednisone (or equivalent). (The previous use or current use of a topical or inhaled corticosteroid was 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 that in the opinion of the investigator might 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, percutaneous transluminal coronary angioplasty)
○ Stroke or transient ischemic neurological disorder (e.g. transient ischemic attack)
New or worsening signs or symptoms of coronary heart disease within the 3 months prior to baseline
New York Heart Association class III or IV congestive heart failure
Uncontrolled hypertension when checked at the screening visit: as evidenced by ≥160 mmHg systolic and/or 100 mmHg diastolic blood pressure (measured in dominant or nondialysis access arm after at least 5 min sitting)
Cancer or diagnosis of malignancy within the last 5 years, except for adequately treated basal or squamous cell skin cancer or adequately treated in situ cervical cancer
Active carpal tunnel syndrome
Patient was, in the opinion of the investigator, mentally or legally incapacitated such that informed consent could not be obtained or such that adherence to the study procedures and dosing regimens was questionable
Patient was, 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 was participating in or had 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 was on potent CYP3A4 inhibitor drugs within 1 week of starting the study drug
