Status:
COMPLETED
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Lead Sponsor:
Palo Alto Veterans Institute for Research
Conditions:
Kidney Failure
Kidney Diseases
Eligibility:
MALE
45-80 years
Phase:
NA
Brief Summary
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 likel...
Detailed Description
All subjects will undergo baseline testing that will consist of functional capacity tests, blood tests and muscle biopsies (described in detail below). Subjects will then receive testosterone gel whic...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00645658
Start Date
August 1 2007
End Date
August 1 2010
Last Update
August 26 2024
Active Locations (2)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
2
Santa Clara Valley Medical Center
San Jose, California, United States, 95128