NCT00645658

Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Palo Alto Veterans Institute for Research · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All subjects will undergo baseline testing that will consist of functional capacity tests, blood tests and muscle biopsies (described in detail below). Subjects will then receive testosterone gel which will be applied daily to the skin of the abdomen or thighs every morning at the same time for 16 weeks. Two days after the hormone treatment is started, the blood testosterone (TT) level will be measured 6 hours after administration. Our goal will be the attainment of serum total TT levels in the mid- to upper normal young adult range. If the serum TT is not at goal, the dose of gel will be increased or decreased repeat testing will be performed within one week. All subjects will be tested for serum TT levels every 4 weeks to assure that the serum total TT remains at goal level. Measurements will be repeated at 8 and 16 weeks.

Conditions

• Kidney Failure
• Kidney Diseases

Interventions

Type	Name	Description
DRUG	Testim, 1% testosterone gel	Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-03-28
• Last updated: 2024-08-26
• Results posted: 2024-08-26

Locations

2 sites across 1 country: United States