A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

University of California Irvine (UCI)

Status: Unknown

Conditions: Kidney Diseases, Chronic; Thyroid Disease

Treatments: Drug: Levothyroxine Sodium; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03191188

HS#2014-1144

R03DK114642 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication of chronic kidney disease that has been associated with impaired quality of life and cardiovascular complications. While levothyroxine is one of the most frequently prescribed medications in chronic kidney disease patients, little is known about its efficacy and safety in this population. This study will investigate 1) whether levothyroxine adequately lowers thyrotropin (TSH) levels to therapeutic target ranges, and 2) if thyroid hormone replacement improves quality of life and cardiovascular markers, without leading to wasting in dialysis patients.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.

Exclusion criteria

• Hyperthyroidism, active treatment with thyroid hormone replacement, prior thyroid malignancy, active pregnancy, active coronary ischemia or atrial fibrillation, osteoporosis, inability to provide consent without a proxy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups, including a placebo group

Levothyroxine

Experimental group

Treatment:

Drug: Levothyroxine Sodium

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet