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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK114642 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine Sodium | Drug | Thyroid hormone supplement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life Short Form 36 questionnaire | Change in Short Form 36 score | Baseline and 12 weeks |
| Serum Growth Differentiation Factor 15 (GDF15) level | Change in GDF15 level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Connie M. Rhee, MD, MSc | Contact | 714-456-5142 | crhee1@uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Connie M. Rhee, MD, MSc | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Dialysis Center of Orange | Recruiting | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28324018 | Background | 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. | |
| 25632971 | Background | 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. |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Placebo Oral Tablet |
| Drug |
Placebo |
|
| Baseline and 12 weeks |
| Serum soluble p-selectin level | Change in soluble p-selectin level | Baseline and 12 weeks |
| Serum soluble CD40 ligand level | Change in serum soluble CD40 ligand level | Baseline and 12 weeks |
| Body mass index | Change in body mass index | Baseline and 12 weeks |
| Biceps skinfold | Change in biceps skinfold | Baseline and 12 weeks |
| Triceps skinfold | Change in triceps skinfold | Baseline and 12 weeks |
| Mid-arm circumference | Change in mid-arm circumference | Baseline and 12 weeks |
| Mid-arm muscle circumference | Change in mid-arm muscle circumference | Baseline and 12 weeks |
| Near infrared body fat percentage | Change in near infrared body fat percentage | Baseline and 12 weeks |
| Subjective Global Assessment questionnaire | Subjective Global Assessment questionnaire score | Baseline and 12 weeks |
| 27525529 | Background | 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. |
| 25246335 | Background | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |