Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT00645658
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.
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT00645658
Study Brief:
Protocol Section:
NCT00645658