Taking people in United StatesNo phase

Levothyroxine for underactive thyroid in people on hemodialysis

Tests levothyroxine against placebo in hemodialysis patients with hypothyroidism.

Key facts

Who runs it: University of California, Irvine
Where: Orange, United StatesSee the site
Trial code: NCT03977207
Registry title: A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
Status: Recruiting
People taking part: 336 people, planned
Started: 20 Jul 2020
Planned end: 30 Nov 2025
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Levothyroxine Sodium
Placebos
Record updated: 8 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults on hemodialysis with mildly raised TSH and normal free thyroxine. It tests levothyroxine against a placebo (dummy pill).

Age: 18 to 75 years
Sex: All sexes
Disease stage: On hemodialysis for at least four weeks. Two TSH results in a row above 3.0 up to 10.0 mIU/L during screening.
Earlier treatment: People cannot join if they are now taking thyroid hormone or anti-thyroid medicines. People who had a kidney transplant before cannot join.
Biomarker or test result: Two TSH levels in a row >3.0-10.0mIU/L and a normal free thyroxine (FT4) level.

Main reasons for not taking part

Current thyroid hormone or anti-thyroid medicine, or an overactive thyroid (TSH <0.5mIU/L)
Prior kidney transplant
Active cancer, past thyroid cancer, or life expectancy under six months
Pregnant or planning a pregnancy
Active heart problems (reduced blood flow to the heart, atrial fibrillation, heart failure flare), osteoporosis, or weight over 450 lbs (204 kg)

This trial only enrols participants on dialysis. The registry sentence this rests on: * Received hemodialysis at least four weeks

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

Age 18-75 years old
Received hemodialysis at least four weeks
Have two consecutive thyrotropin (TSH) levels >3.0-10.0mIU/L during the screening period
Have normal free thyroxine (FT4) levels
Have ability to provide written informed consent

Who cannot take part

Active treatment with thyroid hormone supplementation or anti-thyroid medications
Prior kidney transplantation
Active malignancy or prior thyroid malignancy
Hyperthyroidism as determined by TSH <0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis
Active congestive heart failure exacerbation
Active receipt of dialysis
Life expectancy less than six months
Active pregnancy or planning a pregnancy
Active coronary ischemia or atrial fibrillation (evaluated by EKG)
Osteoporosis
Weight in excess of 450 lbs

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in United States

University of California IrvineOrange, United StatesContact: Kamyar Kalantar-ZadehTaking people

About the trial

What the trial wants to find out

Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication in chronic kidney disease patients, and prior evidence shows that higher TSH levels, even within the normal laboratory range, are strongly associated with impaired quality of life and cardiovascular disease in this population. Levothyroxine is one of the most frequently prescribed medications in chronic kidney disease, yet its efficacy and safety in these patients have not been well-studied. Hence, this study will investigate 1) whether levothyroxine improves patient-centered (e.g., health-related quality of life, physical performance, strength) and 2) cardiovascular (e.g., coronary artery calcification, endothelial function, systolic function) outcomes in dialysis patients, and 3) if thyroid hormone replacement exerts classic metabolic effects (i.e., changes in body fat and resting energy expenditure) in this population.

The 2 groups in the trial

LevothyroxineTreatment being tested
Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\>3.0-5.0 and 5.0-10.0mIU/L) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \>3.0-5.0mIU/L vs. 5.0-10.0mIU/L, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level. The intervention period is 24 weeks. Patients will undergo up to two subsequent dose titrations after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points. Patients whose TSH levels are higher or lower than the therapeutic TSH target of 0.5-3.0mIU/L will undergo a dose adjustment (+/- 25mcg), while those whose TSH levels are in target range will continue the prior dose.
Treatment: Levothyroxine Sodium
PlaceboPlacebo, for comparison
Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\>3.0-5.0 and 5.0-10.0mIU/L) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \>3.0-5.0mIU/L vs. 5.0-10.0mIU/L, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level. The intervention period is 24 weeks. Patients in the placebo arm will undergo an equivalent titration in placebo pills (as that of the experimental arm) after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points.
Treatment: Placebos