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Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

This study has been completed.
Information provided by (Responsible Party):
Kevin Leigh McIntire, Stanford University Identifier:
First received: March 25, 2008
Last updated: May 3, 2012
Last verified: May 2012

March 25, 2008
May 3, 2012
August 2007
August 2010   (final data collection date for primary outcome measure)
  • Lean body mass [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Fat mass [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Thigh cross sectional area [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Fat mass
  • Thigh cross sectional area
  • Lean body mass
Complete list of historical versions of study NCT00645658 on Archive Site
  • Quadriceps strength [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Physical Function [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: pre treatment and monthly until end of treatment ] [ Designated as safety issue: Yes ]
  • Muscle atrophy signaling pathways [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Quadriceps strength
  • Physical Function
  • Quality of Life
  • Inflammatory markers
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Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
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.
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Failure
  • Kidney Diseases
Drug: Testim (1% testosterone gel)
Subjects apply contents of gel packet to skin daily.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2010
August 2010   (final data collection date for primary outcome measure)

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.

45 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
SU-12112007-932, IRB# 10132
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Kevin Leigh McIntire, Stanford University
Stanford University
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Principal Investigator: Ralph Rabkin Stanford University
Stanford University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP