Trial Outcomes & Findings for Testosterone Replacement Therapy in Advanced Chronic Kidney Disease (NCT NCT00645658)
NCT ID: NCT00645658
Last Updated: 2024-08-26
Results Overview
DEXA-determined thigh cross-sectional area
COMPLETED
NA
17 participants
Baseline
2024-08-26
Participant Flow
Participant milestones
| Measure |
Chronic Kidney Disease
Patients with chronic kidney disease between the ages of 55 and 75 years.
Testim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.
|
Control
Control participants with baseline data collection only (for baseline comparator).
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Chronic Kidney Disease
Patients with chronic kidney disease between the ages of 55 and 75 years.
Testim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.
|
Control
Control participants with baseline data collection only (for baseline comparator).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Did not complete all assesments
|
0
|
2
|
Baseline Characteristics
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease
n=9 Participants
Patients with chronic kidney disease between the ages of 55 and 75 years.
Testim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.
|
Control
n=8 Participants
Control participants with baseline data collection only (for baseline comparator).
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
61.3 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
60.7 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.
DEXA-determined thigh cross-sectional area
Outcome measures
| Measure |
Chronic Kidney Disease
n=8 Participants
Patients with chronic kidney disease between the ages of 55 and 75 years.
Testim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.
|
|---|---|
|
Thigh Cross Sectional Area
|
58.2 centimeters squared
Standard Deviation 11
|
PRIMARY outcome
Timeframe: BaselinePopulation: Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.
DEXA-determined lean body mass
Outcome measures
| Measure |
Chronic Kidney Disease
n=8 Participants
Patients with chronic kidney disease between the ages of 55 and 75 years.
Testim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.
|
|---|---|
|
Lean Body Mass
|
48.2 Kg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.
DEXA-determined total body fat mass
Outcome measures
| Measure |
Chronic Kidney Disease
n=8 Participants
Patients with chronic kidney disease between the ages of 55 and 75 years.
Testim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.
|
|---|---|
|
Fat Mass
|
21.2 Kg
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: BaselineLower body strength (in lbs) using quadriceps leg extension.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure data were collected from CKD participants only; CKD participants who completed the protocol are included in the analysis.
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.
Outcome measures
| Measure |
Chronic Kidney Disease
n=8 Participants
Patients with chronic kidney disease between the ages of 55 and 75 years.
Testim (1% testosterone gel): Subjects apply contents of gel packet to skin daily.
|
|---|---|
|
Kidney Disease-Specific Quality of Life
|
42.1 units on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: pre treatment and monthly until end of treatmentC-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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThese include muscle growth regulatory factors, IGF-1 and myostatin, their receptors and components of the ubiquitin-proteasome and calpain proteolytic pathways and inflammatory cytokines.
Outcome measures
Outcome data not reported
Adverse Events
Chronic Kidney Disease
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place