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Hormone Therapy

Levothyroxine for Chronic Kidney Disease

N/A
Waitlist Available
Led By Connie M. Rhee, MD, MSc
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prevalent hemodialysis patients, elevated thyrotropin level, normal free thyroxine level.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

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.

Eligible Conditions
  • Chronic Kidney Disease
  • Thyroid Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of target TSH levels: serum TSH levels ranging from 0.5-3.0mIU/L
Secondary outcome measures
Biceps skinfold
Body mass index
Health-related quality of life Short Form 36 questionnaire
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LevothyroxineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levothyroxine
FDA approved

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,905 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,970 Total Patients Enrolled
Connie M. Rhee, MD, MScPrincipal InvestigatorUniversity of California, Irvine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Journal of Clinical Endocrinology & MetabolismJournal
Thyroid Status and Mortality in a Prospective Hemodialysis Cohort
Rhee, Connie M., Amy S. You, Danh V. Nguyen, Steven M. Brunelli, Matthew J. Budoff, Elani Streja, Tracy Nakata, Csaba P. Kovesdy, Gregory A. Brent, and Kamyar Kalantar-Zadeh. 2017. “Thyroid Status and Mortality in a Prospective Hemodialysis Cohort”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2016-3616.
The Journal of Clinical Endocrinology & MetabolismJournal
Association of Thyroid Functional Disease with Mortality in a National Cohort of Incident Hemodialysis Patients
Rhee, Connie M., Steven Kim, Daniel L. Gillen, Tolga Oztan, Jiaxi Wang, Rajnish Mehrotra, Sooraj Kuttykrishnan, et al.. 2015. “Association of Thyroid Functional Disease with Mortality in a National Cohort of Incident Hemodialysis Patients”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2014-4311.
The Journal of Clinical Endocrinology & MetabolismJournal
Thyroid Functional Disease and Mortality in a National Peritoneal Dialysis Cohort
Rhee, Connie M., Vanessa A. Ravel, Elani Streja, Rajnish Mehrotra, Steven Kim, Jiaxi Wang, Danh V. Nguyen, Csaba P. Kovesdy, Gregory A. Brent, and Kamyar Kalantar-Zadeh. 2016. “Thyroid Functional Disease and Mortality in a National Peritoneal Dialysis Cohort”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2016-1691.
clinicaltrials.govStudy
A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients
2017. "A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03191188.
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