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Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Not Recruiting
Trial ID: NCT00645658
Purpose
Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects
morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are
reduced, and likely contributes to the wasting. As TT in relatively safe physiologic
replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we
hypothesize that physiologic TT replacement will be effective in preventing and treating the
loss of muscle mass and function in CKD patients, will improve quality of life and may reduce
some cardiovascular disease (CVD) risk factors.
Official Title
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Stanford Investigator(s)
Eligibility
Inclusion Criteria:Inclusion criteria: CKD subjects; males with calculated GFR (MRDR
equation) between 15 and 40 ml/min/1.73m2 and stable or slowly progressive renal failure
(decline in function of <1ml/min/month) including those patients requiring hemodialysis and
serum testosterone levels of <300 ng/ml and capable of safely performing required exercise
testing and serum testosterone levels of <300ng/ml and capable of safely performing
required exercise testing.
Control subjects; good health, normal serum creatinine levels, normal TT levels and able to
perform required exercise testing safely. The racial and ethnic composition of the subjects
will reflect the composition present in the ESRD population in the counties in Northern
California from which our patients are referred. Subjects to be of age 45-80 years.
Exclusion Criteria:Exclusion criteria: applicable to both CKD and control subjects. Any
unstable chronic medical condition, previous kidney transplant. Uncontrolled diabetes
mellitus, active vasculitis, active autoimmune disease, malignancy(<5 yrs), obesity (BMI >
35), alcoholism or other recreational drug use, active heart disease, angina, uncontrolled
arrhythmias or myocardial infarct within past 3 months, peripheral vascular disease with
claudication, active lung, liver or GI disease, sleep apnea, medically unstable subjects
and subjects who received anabolic, catabolic or cytotoxic medications during the prior 3
months. History of prostate CA, PSA >4g/ml, or advanced BPH (AUA symptom score > 21) and
abnormal prostate on digital rectal examination. Bone or joint abnormalities that would
preclude exercise testing.
Intervention(s):
drug: Testim (1% testosterone gel)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305