| Trial ID: | L0144 |
| Source ID: | NCT00645658
|
| Associated Drug: |
Testim, 1% Testosterone Gel
|
| Title: |
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00645658/results
|
| Conditions: |
Kidney Failure|Kidney Diseases
|
| Interventions: |
DRUG: Testim, 1% testosterone gel
|
| Outcome Measures: |
Primary: Thigh Cross Sectional Area, DEXA-determined thigh cross-sectional area, Baseline|Lean Body Mass, DEXA-determined lean body mass, Baseline | Secondary: Fat Mass, DEXA-determined total body fat mass, Baseline|Quadriceps Strength, Lower body strength (in lbs) using quadriceps leg extension., Baseline|Kidney Disease-Specific Quality of Life, Questionnaire - SF-36, which stands for the Short Form 36 Health Survey. It is a widely used standardized 36 item quality of life assessment. This particular measure focused on symptoms, and is scaled from zero to 100, with a higher score indicating better health functioning., Baseline|Inflammatory Markers, C-Reactive Protein (CRP). CRP is measured in mg/l and is a marker of inflammation. CRP generally ranges from \<1.0 to 5 mg/L. A normal value is less than 2.0 mg/L., pre treatment and monthly until end of treatment|Muscle Atrophy Signaling Pathways, These include muscle growth regulatory factors, IGF-1 and myostatin, their receptors and components of the ubiquitin-proteasome and calpain proteolytic pathways and inflammatory cytokines., Baseline
|
| Sponsor/Collaborators: |
Sponsor: Palo Alto Veterans Institute for Research
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
17
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-08
|
| Completion Date: |
2010-08
|
| Results First Posted: |
2024-08-26
|
| Last Update Posted: |
2024-08-26
|
| Locations: |
VA Palo Alto Health Care System, Palo Alto, California, 94304, United States|Santa Clara Valley Medical Center, San Jose, California, 95128, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00645658
|
