A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Thyroid Disease, Kidney Diseases, Chronic
In brief
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.
Key facts
- Study ID
- NCT03191188
- Run by
- University of California, Irvine
- People needed
- 96
- Starts
- 2017-07-01
- Expected to finish
- 2021-07-01
- Last updated by the study team
- 2021-06-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.
You may not qualify if…
- 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.
Where it is running
- University Dialysis Center of Orange — Orange, California, United States (enrolling)
Full record on ClinicalTrials.gov
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