Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

Kidney Diseases Clinical Trial

Official title:

Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645658
• Other study ID #: SU-12112007-932
• Secondary ID: IRB# 10132
• Status: Completed
• Phase: N/A
• First received: March 25, 2008
• Last updated: May 3, 2012
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: May 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Santa Clara Valley Medical Center	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean body mass		pre and post treatment	No
Primary	Fat mass		pre and post treatment	No
Primary	Thigh cross sectional area		pre and post treatment	No
Secondary	Quadriceps strength		pre and post treatment	No
Secondary	Physical Function		pre and post treatment	No
Secondary	Quality of Life		pre and post treatment	No
Secondary	Inflammatory markers		pre treatment and monthly until end of treatment	Yes
Secondary	Muscle atrophy signaling pathways		pre and post treatment	No