Trial Search Results

Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Testim (1% testosterone gel)

Phase:

N/A

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.

Ages Eligible for Study

45 Years - 80 Years

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting