Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
2 other identifiers
interventional
17
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2007
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
August 26, 2024
CompletedAugust 26, 2024
July 1, 2024
3 years
March 25, 2008
November 22, 2022
July 31, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Thigh Cross Sectional Area
DEXA-determined thigh cross-sectional area
Baseline
Lean Body Mass
DEXA-determined lean body mass
Baseline
Secondary Outcomes (5)
Fat Mass
Baseline
Quadriceps Strength
Baseline
Kidney Disease-Specific Quality of Life
Baseline
Inflammatory Markers
pre treatment and monthly until end of treatment
Muscle Atrophy Signaling Pathways
Baseline
Study Arms (2)
Chronic kidney disease
EXPERIMENTALPatients with chronic kidney disease between the ages of 55 and 75 years.
Control
NO INTERVENTIONControl participants with baseline data collection only (for baseline comparator).
Interventions
Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitation of funding period led to a small number of participants analyzed.
Results Point of Contact
- Title
- Jonathan Myers
- Organization
- VA Palo Alto Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Rabkin
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
March 25, 2008
First Posted
March 28, 2008
Study Start
August 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 26, 2024
Results First Posted
August 26, 2024
Record last verified: 2024-07