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Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
This study is currently recruiting participants.
Verified by Stanford University, March 2009
First Received: March 25, 2008   Last Updated: March 20, 2009   History of Changes
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00645658
  Purpose

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.


Condition Intervention
Kidney Failure
Kidney Diseases
Drug: Testim (1% testosterone gel)

MedlinePlus related topics: Kidney Failure
Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

Further study details as provided by Stanford University:

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

Estimated Enrollment: 48
Study Start Date: August 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645658

Contacts
Contact: Kevin L McIntire, PhD (650) 493-5000 ext 63566 kevinmc1@stanford.edu

Locations
United States, California
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Anjali Saxena     408-885-7763        
Sub-Investigator: Anjali Saxena            
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Kevin L McIntire, PhD     650-493-5000 ext 63566     kevinmc1@stanford.edu    
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ralph Rabkin Stanford University
  More Information

No publications provided

Responsible Party: Stanford University School of Medicine ( Kevin L McIntire, PhD )
Study ID Numbers: SU-12112007-932, IRB# 10132
Study First Received: March 25, 2008
Last Updated: March 20, 2009
ClinicalTrials.gov Identifier: NCT00645658     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Renal Insufficiency
Antineoplastic Agents, Hormonal
Hormone Antagonists
Kidney Failure, Chronic
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure
Androgens

Additional relevant MeSH terms:
Renal Insufficiency
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Kidney Failure, Chronic
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Kidney Failure
Androgens

ClinicalTrials.gov processed this record on May 07, 2009