Clinical trial NCT03191188: A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
Official title: A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Disease
Kidney Diseases, Chronic
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-06-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L
timeFrame: 12 weeks
Secondary outcomes:
measure: Health-related quality of life Short Form 36 questionnaire
timeFrame: Baseline and 12 weeks
measure: Serum Growth Differentiation Factor 15 (GDF15) level
timeFrame: Baseline and 12 weeks
measure: Serum soluble p-selectin level
timeFrame: Baseline and 12 weeks
measure: Serum soluble CD40 ligand level
timeFrame: Baseline and 12 weeks
measure: Body mass index
timeFrame: Baseline and 12 weeks
measure: Biceps skinfold
timeFrame: Baseline and 12 weeks
measure: Triceps skinfold
timeFrame: Baseline and 12 weeks
measure: Mid-arm circumference
timeFrame: Baseline and 12 weeks
measure: Mid-arm muscle circumference
timeFrame: Baseline and 12 weeks
measure: Near infrared body fat percentage
timeFrame: Baseline and 12 weeks
measure: Subjective Global Assessment questionnaire
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: University Dialysis Center of Orange
state: California
Study officials:
affiliation: University of California, Irvine
name: Connie M. Rhee, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616.
citation: Rhee CM, Kim S, Gillen DL, Oztan T, Wang J, Mehrotra R, Kuttykrishnan S, Nguyen DV, Brunelli SM, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Association of thyroid functional disease with mortality in a national cohort of incident hemodialysis patients. J Clin Endocrinol Metab. 2015 Apr;100(4):1386-95. doi: 10.1210/jc.2014-4311. Epub 2015 Jan 29.
citation: Rhee CM, Ravel VA, Streja E, Mehrotra R, Kim S, Wang J, Nguyen DV, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Functional Disease and Mortality in a National Peritoneal Dialysis Cohort. J Clin Endocrinol Metab. 2016 Nov;101(11):4054-4061. doi: 10.1210/jc.2016-1691. Epub 2016 Aug 15.
citation: Rhee CM, Kalantar-Zadeh K, Streja E, Carrero JJ, Ma JZ, Lu JL, Kovesdy CP. The relationship between thyroid function and estimated glomerular filtration rate in patients with chronic kidney disease. Nephrol Dial Transplant. 2015 Feb;30(2):282-7. doi: 10.1093/ndt/gfu303. Epub 2014 Sep 21.