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A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

Primary Purpose

Thyroid Disease, Kidney Diseases, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine Sodium
Placebo Oral Tablet
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Dialysis Center of OrangeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levothyroxine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Health-related quality of life Short Form 36 questionnaire
Change in Short Form 36 score
Serum Growth Differentiation Factor 15 (GDF15) level
Change in GDF15 level
Serum soluble p-selectin level
Change in soluble p-selectin level
Serum soluble CD40 ligand level
Change in serum soluble CD40 ligand level
Body mass index
Change in body mass index
Biceps skinfold
Change in biceps skinfold
Triceps skinfold
Change in triceps skinfold
Mid-arm circumference
Change in mid-arm circumference
Mid-arm muscle circumference
Change in mid-arm muscle circumference
Near infrared body fat percentage
Change in near infrared body fat percentage
Subjective Global Assessment questionnaire
Subjective Global Assessment questionnaire score

Full Information

First Posted
June 13, 2017
Last Updated
June 9, 2021
Sponsor
University of California, Irvine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03191188
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Disease, Kidney Diseases, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levothyroxine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levothyroxine Sodium
Intervention Description
Thyroid hormone supplement
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L
Description
Number of patients achieving target TSH levels of 0.5-3.0mIU/L
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life Short Form 36 questionnaire
Description
Change in Short Form 36 score
Time Frame
Baseline and 12 weeks
Title
Serum Growth Differentiation Factor 15 (GDF15) level
Description
Change in GDF15 level
Time Frame
Baseline and 12 weeks
Title
Serum soluble p-selectin level
Description
Change in soluble p-selectin level
Time Frame
Baseline and 12 weeks
Title
Serum soluble CD40 ligand level
Description
Change in serum soluble CD40 ligand level
Time Frame
Baseline and 12 weeks
Title
Body mass index
Description
Change in body mass index
Time Frame
Baseline and 12 weeks
Title
Biceps skinfold
Description
Change in biceps skinfold
Time Frame
Baseline and 12 weeks
Title
Triceps skinfold
Description
Change in triceps skinfold
Time Frame
Baseline and 12 weeks
Title
Mid-arm circumference
Description
Change in mid-arm circumference
Time Frame
Baseline and 12 weeks
Title
Mid-arm muscle circumference
Description
Change in mid-arm muscle circumference
Time Frame
Baseline and 12 weeks
Title
Near infrared body fat percentage
Description
Change in near infrared body fat percentage
Time Frame
Baseline and 12 weeks
Title
Subjective Global Assessment questionnaire
Description
Subjective Global Assessment questionnaire score
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie M. Rhee, MD, MSc
Phone
714-456-5142
Email
crhee1@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie M. Rhee, MD, MSc
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Dialysis Center of Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamyar Kalantar-Zadeh, MD, MPH, PhD
Phone
714-634-3583
Email
kkz@uci.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28324018
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.
Results Reference
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PubMed Identifier
25632971
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.
Results Reference
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PubMed Identifier
27525529
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.
Results Reference
background
PubMed Identifier
25246335
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.
Results Reference
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A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

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