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Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

Primary Purpose

Kidney Failure, Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testim (1% testosterone gel)
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Control subjects; good health, normal serum creatinine levels, normal TT levels and able to perform required exercise testing safely. The racial and ethnic composition of the subjects will reflect the composition present in the ESRD population in the counties in Northern California from which our patients are referred. Subjects to be of age 45-80 years. 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.

Sites / Locations

  • VA Palo Alto Health Care System
  • Santa Clara Valley Medical Center

Outcomes

Primary Outcome Measures

Lean body mass
Fat mass
Thigh cross sectional area

Secondary Outcome Measures

Quadriceps strength
Physical Function
Quality of Life
Inflammatory markers
Muscle atrophy signaling pathways

Full Information

First Posted
March 25, 2008
Last Updated
May 3, 2012
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00645658
Brief Title
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Official Title
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Testim (1% testosterone gel)
Intervention Description
Subjects apply contents of gel packet to skin daily.
Primary Outcome Measure Information:
Title
Lean body mass
Time Frame
pre and post treatment
Title
Fat mass
Time Frame
pre and post treatment
Title
Thigh cross sectional area
Time Frame
pre and post treatment
Secondary Outcome Measure Information:
Title
Quadriceps strength
Time Frame
pre and post treatment
Title
Physical Function
Time Frame
pre and post treatment
Title
Quality of Life
Time Frame
pre and post treatment
Title
Inflammatory markers
Time Frame
pre treatment and monthly until end of treatment
Title
Muscle atrophy signaling pathways
Time Frame
pre and post treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Control subjects; good health, normal serum creatinine levels, normal TT levels and able to perform required exercise testing safely. The racial and ethnic composition of the subjects will reflect the composition present in the ESRD population in the counties in Northern California from which our patients are referred. Subjects to be of age 45-80 years. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Rabkin
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States

12. IPD Sharing Statement

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Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

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