Andrew R. Hoffman
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Contact Information
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
Condition(s):
Intervention(s):
- Drug: Testim (1% testosterone gel)
Phase:
N/AEligibility
Ages Eligible for Study:
45 years to 80 yearsGenders Eligible for Study:
MaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key 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.
Additional Study Details
Official Title:
Testosterone Replacement Therapy in Advanced Chronic Kidney DiseaseAnticipated start date:
8/1/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
- Ralph Rabkin
- Anne L. Friedlander
- Andrew R Hoffman
- Kevin Leigh McIntire
- John Drace
- Dr Yiming Zhao Lit
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Lean body mass
- Fat mass
- Thigh cross sectional area
Secondary Outcomes:
- Quadriceps strength
- Physical Function
- Quality of Life
- Inflammatory markers
- Muscle atrophy signaling pathways
Total Number to be Enrolled:
48Total Number to be Enrolled at Stanford:
48More Information
Secondary ID(s):
- IRB# 10132
Locations & Contacts
Stanford Locations & Contacts:
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
3/18/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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