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Status unknownNCT03191188Updated Jun 14, 2021

A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

An interventional study of Levothyroxine Sodium and Placebo Oral Tablet in Thyroid Disease and Kidney Diseases, Chronic, sponsored by University of California, Irvine. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Thyroid Disease
  • Kidney Diseases, Chronic
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 96 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Levothyroxine

    Drug: Levothyroxine Sodium

  • Placebo comparator
    Placebo

    Drug: Placebo Oral Tablet

Interventions

  • DrugLevothyroxine Sodium

    Thyroid hormone supplement

  • DrugPlacebo Oral Tablet

    Placebo

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What researchers measure

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

    Time frame: 12 weeks

Secondary outcomes

  1. Health-related quality of life Short Form 36 questionnaire

    Change in Short Form 36 score

    Time frame: Baseline and 12 weeks

  2. Serum Growth Differentiation Factor 15 (GDF15) level

    Change in GDF15 level

    Time frame: Baseline and 12 weeks

  3. Serum soluble p-selectin level

    Change in soluble p-selectin level

    Time frame: Baseline and 12 weeks

  4. Serum soluble CD40 ligand level

    Change in serum soluble CD40 ligand level

    Time frame: Baseline and 12 weeks

  5. Body mass index

    Change in body mass index

    Time frame: Baseline and 12 weeks

  6. Biceps skinfold

    Change in biceps skinfold

    Time frame: Baseline and 12 weeks

  7. Triceps skinfold

    Change in triceps skinfold

    Time frame: Baseline and 12 weeks

  8. Mid-arm circumference

    Change in mid-arm circumference

    Time frame: Baseline and 12 weeks

  9. Mid-arm muscle circumference

    Change in mid-arm muscle circumference

    Time frame: Baseline and 12 weeks

  10. Near infrared body fat percentage

    Change in near infrared body fat percentage

    Time frame: Baseline and 12 weeks

  11. Subjective Global Assessment questionnaire

    Subjective Global Assessment questionnaire score

    Time frame: Baseline and 12 weeks

07

Study locations

1 of 1 sites recruiting
  • University Dialysis Center of Orange
    Orange, California 92868, United States
    • Kamyar Kalantar-Zadeh, MD, MPH, PhD · Contact · kkz@uci.edu · 714-634-3583
    Recruiting
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References and documents

Publications

  • 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. PubMed 28324018 ↗
  • 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. PubMed 25632971 ↗
  • 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. PubMed 27525529 ↗
  • 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. PubMed 25246335 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03191188
Lead sponsor
University of California, Irvine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Jun 19, 2017
Start date
Jul 1, 2017
Primary completion
Jul 2021 (estimated)
Completion
Jul 2021 (estimated)
Last update
Jun 14, 2021

Study contacts

Connie M. Rhee, MD, MSc
Contact
crhee1@uci.edu
714-456-5142
Connie M. Rhee, MD, MSc
principal investigator · University of California, Irvine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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