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New treatment option for Thyroid; Functional Disturbance
Official title A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
ClinicalTrials.gov ID: NCT03977207
What this study is testing
What is Levothyroxine Sodium?
Levothyroxine Sodium is an investigational medicine, being studied as a potential treatment for thyroid; functional disturbance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- Active treatment with thyroid hormone supplementation or anti-thyroid medications
- Active receipt of dialysis
- Prior kidney transplantation
- Life expectancy less than six months
- Active malignancy or prior thyroid malignancy
- Active pregnancy or planning a pregnancy
See the full eligibility criteria
- 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
- Active treatment with thyroid hormone supplementation or anti-thyroid medications
- Active receipt of dialysis
- Prior kidney transplantation
- Life expectancy less than six months
- Active malignancy or prior thyroid malignancy
- Active pregnancy or planning a pregnancy
- Active coronary ischemia or atrial fibrillation (evaluated by EKG)
- Active congestive heart failure exacerbation
- Osteoporosis
- Weight in excess of 450 lbs.
- Hyperthyroidism as determined by TSH \<0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.