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Sponsored by: |
Stanford University |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00645658 |
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.
Condition | Intervention |
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Kidney Failure Kidney Diseases |
Drug: Testim (1% testosterone gel) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Testosterone Replacement Therapy in Advanced Chronic Kidney Disease |
Estimated Enrollment: | 48 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.
Contact: Kevin L McIntire, PhD | (650) 493-5000 ext 63566 | kevinmc1@stanford.edu |
United States, California | |
Santa Clara Valley Medical Center | Recruiting |
San Jose, California, United States, 95128 | |
Contact: Anjali Saxena 408-885-7763 | |
Sub-Investigator: Anjali Saxena | |
VA Palo Alto Health Care System | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Kevin L McIntire, PhD 650-493-5000 ext 63566 kevinmc1@stanford.edu |
Principal Investigator: | Ralph Rabkin | Stanford University |
Responsible Party: | Stanford University School of Medicine ( Kevin L McIntire, PhD ) |
Study ID Numbers: | SU-12112007-932, IRB# 10132 |
Study First Received: | March 25, 2008 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00645658 History of Changes |
Health Authority: | United States: Institutional Review Board |
Renal Insufficiency Antineoplastic Agents, Hormonal Hormone Antagonists Kidney Failure, Chronic Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Hormones Testosterone 17 beta-cypionate |
Anabolic Agents Testosterone Urologic Diseases Renal Insufficiency, Chronic Kidney Diseases Kidney Failure Androgens |
Renal Insufficiency Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Kidney Failure, Chronic Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Hormones Pharmacologic Actions |
Testosterone 17 beta-cypionate Anabolic Agents Testosterone Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Kidney Diseases Kidney Failure Androgens |