Thyroid Hormone Supplementation for Hypothyroidism in Hemodialysis Patients
(THYROID-HD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if levothyroxine, a thyroid hormone replacement, can improve quality of life and heart health in dialysis patients with slightly high TSH levels. The medication aims to balance their thyroid hormone levels. Levothyroxine is a commonly used thyroid hormone replacement therapy that has been shown to improve heart function and physical activity without significant side effects.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively taking thyroid hormone supplements or anti-thyroid medications.
Is levothyroxine generally safe for humans?
Levothyroxine is generally safe for humans, but there are rare cases of liver injury, especially if the dose is increased too quickly. It's important to start with a low dose and increase gradually, especially in older adults or those with heart disease, to avoid potential side effects like heart problems or bone loss.12345
How is the drug Levothyroxine Sodium unique for treating hypothyroidism in hemodialysis patients?
Levothyroxine Sodium is unique because it can be administered intravenously during hemodialysis sessions, which is beneficial for patients who cannot take oral medications. This method ensures that patients with severe hypothyroidism and non-adherence to oral treatments receive the necessary thyroid hormone replacement.26789
What data supports the effectiveness of the drug Levothyroxine Sodium for hypothyroidism in hemodialysis patients?
Are You a Good Fit for This Trial?
This trial is for people aged 18-75 on hemodialysis with mild to moderate hypothyroidism, not currently treated for thyroid issues. They must have stable heart function and no severe bone disease, weigh less than 450 lbs., and not be pregnant or planning pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive levothyroxine or placebo for 24 weeks with dose titrations at 8 and 16 weeks based on TSH levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Levothyroxine Sodium
- Placebos
Levothyroxine Sodium is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Hypothyroidism
- Thyroid nodules
- Thyroid cancer
- Hypothyroidism
- Thyroid nodules
- Thyroid cancer
- Goiter
- Hypothyroidism
- Thyroid nodules
- Thyroid cancer
- Hypothyroidism
- Thyroid nodules
- Thyroid cancer
- Hypothyroidism
- Thyroid nodules
- Thyroid cancer
- Hypothyroidism
- Thyroid nodules
- Thyroid cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator