A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

Thyroid Disease Clinical Trial

Official title:

A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191188
• Other study ID #: HS#2014-1144
• Secondary ID: R03DK114642
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 2021

Study information

• Verified date: June 2021
• Source: University of California, Irvine
• Contact: Connie M. Rhee, MD, MSc
• Phone: 714-456-5142
• Email: crhee1[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Diseases, Chronic
• Renal Insufficiency, Chronic
• Thyroid Disease
• Thyroid Diseases

Intervention

Drug:
• Levothyroxine Sodium
Thyroid hormone supplement
• Placebo Oral Tablet
Placebo

Locations

Country	Name	City	State
United States	University Dialysis Center of Orange	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Epub 2016 Aug 15. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L	Number of patients achieving target TSH levels of 0.5-3.0mIU/L	12 weeks
Secondary	Health-related quality of life Short Form 36 questionnaire	Change in Short Form 36 score	Baseline and 12 weeks
Secondary	Serum Growth Differentiation Factor 15 (GDF15) level	Change in GDF15 level	Baseline and 12 weeks
Secondary	Serum soluble p-selectin level	Change in soluble p-selectin level	Baseline and 12 weeks
Secondary	Serum soluble CD40 ligand level	Change in serum soluble CD40 ligand level	Baseline and 12 weeks
Secondary	Body mass index	Change in body mass index	Baseline and 12 weeks
Secondary	Biceps skinfold	Change in biceps skinfold	Baseline and 12 weeks
Secondary	Triceps skinfold	Change in triceps skinfold	Baseline and 12 weeks
Secondary	Mid-arm circumference	Change in mid-arm circumference	Baseline and 12 weeks
Secondary	Mid-arm muscle circumference	Change in mid-arm muscle circumference	Baseline and 12 weeks
Secondary	Near infrared body fat percentage	Change in near infrared body fat percentage	Baseline and 12 weeks
Secondary	Subjective Global Assessment questionnaire	Subjective Global Assessment questionnaire score	Baseline and 12 weeks