Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: August 2010

Interventions Used in this Clinical Trial

  • Drug: Testim (1% testosterone gel)
    • Subjects apply contents of gel packet to skin daily.

Outcome Measures for this Clinical Trial

Primary Measures

  • Lean body mass
    • Time Frame: pre and post treatment
      Safety Issue?: No
  • Fat mass
    • Time Frame: pre and post treatment
      Safety Issue?: No
  • Thigh cross sectional area
    • Time Frame: pre and post treatment
      Safety Issue?: No

Secondary Measures

  • Quadriceps strength
    • Time Frame: pre and post treatment
      Safety Issue?: No
  • Physical Function
    • Time Frame: pre and post treatment
      Safety Issue?: No
  • Quality of Life
    • Time Frame: pre and post treatment
      Safety Issue?: No
  • Inflammatory markers
    • Time Frame: pre treatment and monthly until end of treatment
      Safety Issue?: Yes
  • Muscle atrophy signaling pathways
    • Time Frame: pre and post treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kevin Leigh McIntire, Postdoctoral Scholar – Stanford University
  • Overall Official(s)
    • Ralph Rabkin, Principal Investigator, Stanford University

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00645658