Kidney FailureNCT00645658
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
A study testing Testim, 1% testosterone gel in people with Kidney Failure and Kidney Diseases, run by Palo Alto Veterans Institute for Research at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Kidney Failure, Kidney Diseases
- What is being tested?
- Testim, 1% testosterone gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System
Palo Alto, California, 94304
Santa Clara Valley Medical Center
San Jose, California, 95128
About this study
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.
Read the 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
- Being tested
- Testim, 1% testosterone gel
- Medical subject headings
- Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testim, 1% testosterone gelDrug
Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Experimental | Patients with chronic kidney disease between the ages of 55 and 75 years. Receives: Drug: Testim, 1% testosterone gel |
| Control | No intervention | Control participants with baseline data collection only (for baseline comparator). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh Cross Sectional Area
DEXA-determined thigh cross-sectional area
Measured: Baseline
Lean Body Mass
DEXA-determined lean body mass
Measured: Baseline
Secondary outcomes (5)
Fat Mass
DEXA-determined total body fat mass
Measured: Baseline
Quadriceps Strength
Lower body strength (in lbs) using quadriceps leg extension.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Myers, Palo Alto Veterans Institute for Research
- Investigators
- Ralph Rabkin, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645658
- Sponsor's protocol ID
- RAB0015AGG/SGG
- Other IDs
- IRB# 10132
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2008
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00645658
- Acronym / sponsor ID
- RAB0015AGG/SGG
- Conditions
- Kidney Failure, Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | Experimental | Drug: Testim, 1% testosterone gelPatients with chronic kidney disease between the ages of 55 and 75 years. |
| Control | No intervention | –Control participants with baseline data collection only (for baseline comparator). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testim, 1% testosterone gelSubjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily. | Drug | Chronic kidney disease |
Primary outcome
Thigh Cross Sectional Area
Time frame: Baseline
DEXA-determined thigh cross-sectional area
Lean Body Mass
Time frame: Baseline
DEXA-determined lean body mass
5 secondary outcomes
Fat Mass
Time frame: Baseline
Quadriceps Strength
Time frame: Baseline
Kidney Disease-Specific Quality of Life
Time frame: Baseline
Inflammatory Markers
Time frame: pre treatment and monthly until end of treatment
Muscle Atrophy Signaling Pathways
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Rabkin principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testim, 1% testosterone gel in people with Kidney Failure and Kidney Diseases, run by Palo Alto Veterans Institute for Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh Cross Sectional Area (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.