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Hormone Therapy

A Pilot Feasibility Trial of Thyroid Hormone Replacement in Dialysis Patients

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
Approved for 10 Other Conditions
All Individual Drugs Already Approved

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
  • Thyroid Disease
  • Chronic Kidney 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

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

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
566 Previous Clinical Trials
1,932,952 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,357 Total Patients Enrolled
Connie M. Rhee, MD, MScPrincipal InvestigatorUniversity of California, Irvine
~11 spots leftby Jan 2026
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