Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Leigh McIntire, Stanford University
ClinicalTrials.gov Identifier:
NCT00645658
First received: March 25, 2008
Last updated: May 3, 2012
Last verified: May 2012
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Lean body mass [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Fat mass [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Thigh cross sectional area [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quadriceps strength [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Physical Function [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: pre treatment and monthly until end of treatment ] [ Designated as safety issue: Yes ]
  • Muscle atrophy signaling pathways [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Testim (1% testosterone gel)
    Subjects apply contents of gel packet to skin daily.
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00645658

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ralph Rabkin Stanford University
  More Information

No publications provided

Responsible Party: Kevin Leigh McIntire, Postdoctoral Scholar, Stanford University
ClinicalTrials.gov Identifier: NCT00645658     History of Changes
Other Study ID Numbers: SU-12112007-932, IRB# 10132
Study First Received: March 25, 2008
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014