Testosterone Treatment in Men with Chronic Kidney Disease

Inclusion Criteria:

• Men between ages of 18-85 years of age

• eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation

• Subnormal total serum T concentrations (<300 ng/dl) on two separate occasions inmorning

• Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectiledysfunction, fatigue, irritability, depressed mood, poor concentration, increasedbody fat, decreased muscle bulk, reduced physical performance, sleep disturbance,loss of body hair (15)

• Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrinsaturation (TSAT) ≥20%.

Exclusion Criteria:

• Use of TRT currently or in the past 6 months, including use of over-the-counterandrogen containing health supplements (e.g., DHEA)

• Hematocrit >48% (as per Endocrine Society guidelines)(15)

• Treatment with erythropoiesis stimulating agents (ESA)

• Uncontrolled blood pressure (>180/100 mm Hg)

• Heart Failure, class III or IV

• Myocardial infarction, stroke, or heart surgery in the past 3 months

• Breast cancer

• History of prostate cancer

• Prostate specific antigen (PSA) >4 ng/ml, unless prostate cancer has been ruled outby a urologist (documented in physician notes)

• HIV or untreated hepatitis C

• Untreated, severe obstructive sleep apnea

• Initiated iron replacement in the last 3 months

• deep venous thrombosis or pulmonary embolism in the last 3 months

• recurrent (more than once) deep venous thrombosis or pulmonary embolism

• use of warfarin

• Planning to have children in the next one year