A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

NCT03191188 | Unknown DMC

• 2 other identifiers: HS#2014-1144R03DK114642
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Disease; Kidney Diseases, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Health-related quality of life Short Form 36 questionnaire

  Baseline and 12 weeks

• Serum Growth Differentiation Factor 15 (GDF15) level

  Baseline and 12 weeks

• Serum soluble p-selectin level

  Baseline and 12 weeks

• Serum soluble CD40 ligand level

  Baseline and 12 weeks

• Body mass index

  Baseline and 12 weeks

Study Arms (2)

Levothyroxine

EXPERIMENTAL

Drug: Levothyroxine Sodium

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Levothyroxine Sodium DRUG

Thyroid hormone supplement

Levothyroxine

Placebo Oral Tablet DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University Dialysis Center of Orange

Orange, California, 92868, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 28324018 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.

  PMID: 25632971 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.

  PMID: 27525529 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.

  PMID: 25246335 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases; Renal Insufficiency, Chronic

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Connie M. Rhee, MD, MSc

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connie M. Rhee, MD, MSc

CONTACT

714-456-5142; crhee1@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 19, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)