336 Participants Needed

Thyroid Hormone Supplementation for Hypothyroidism in Hemodialysis Patients

(THYROID-HD Trial)

CR
Overseen ByConnie Rhee, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

What data supports the effectiveness of the drug Levothyroxine Sodium for hypothyroidism in hemodialysis patients?

Research shows that Levothyroxine Sodium can help manage hypothyroidism in patients with kidney issues, as it has been effective in preventing worsening kidney function and improving nutritional status in patients with chronic kidney disease.12345

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.16789

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.1351011

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.

Eligibility Criteria

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

Have ability to provide written informed consent
I have been on hemodialysis for at least four weeks.
Your thyroid test results show that your TSH levels are consistently between 3.0 and 10.0mIU/L.
See 1 more

Exclusion Criteria

I am currently taking medication for my thyroid condition.
I am currently on dialysis.
I am currently experiencing worsening heart failure symptoms.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive levothyroxine or placebo for 24 weeks with dose titrations at 8 and 16 weeks based on TSH levels

24 weeks
Regular visits for dose titration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Levothyroxine Sodium
  • Placebos
Trial Overview The study tests if Levothyroxine improves life quality and cardiovascular health in dialysis patients compared to a placebo. It also looks at metabolic effects like changes in body fat and energy use.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LevothyroxineExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Levothyroxine Sodium is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Levothyroxine Sodium for:
  • Hypothyroidism
  • Thyroid nodules
  • Thyroid cancer
🇺🇸
Approved in United States as Levothyroxine Sodium for:
  • Hypothyroidism
  • Thyroid nodules
  • Thyroid cancer
  • Goiter
🇨🇦
Approved in Canada as Levothyroxine Sodium for:
  • Hypothyroidism
  • Thyroid nodules
  • Thyroid cancer
🇯🇵
Approved in Japan as Levothyroxine Sodium for:
  • Hypothyroidism
  • Thyroid nodules
  • Thyroid cancer
🇨🇳
Approved in China as Levothyroxine Sodium for:
  • Hypothyroidism
  • Thyroid nodules
  • Thyroid cancer
🇨🇭
Approved in Switzerland as Levothyroxine Sodium for:
  • Hypothyroidism
  • Thyroid nodules
  • Thyroid cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

Levothyroxine sodium treatment effectively prevented progressive renal failure in a 49-year-old female patient with diabetes and hypothyroidism over a period of more than 24 months.
Before treatment, the patient's renal function worsened, as indicated by a negative slope in serum creatinine levels, which improved to a positive slope after starting levothyroxine, suggesting its efficacy in stabilizing renal function.
Prevention of progressive renal failure by levothyroxine sodium in a diabetic patient with renal insufficiency and hypothyroidism.Miura, M., Nomoto, Y., Sakai, H.[2019]
In a study of 200 patients with stage 3-4 chronic kidney disease (CKD), treatment with levothyroxine improved nutritional indicators such as weight, grip strength, hemoglobin, and serum albumin compared to a control group.
Levothyroxine treatment also led to an increase in estimated glomerular filtration rate (eGFR) in the treatment group, indicating a delay in kidney disease progression, particularly more effective in patients with stage 3 CKD than in those with stage 4.
FAVORABLE EFFECT OF LEVOTHYROXINE ON NUTRITIONAL STATUS OF PATIENTS WITH STAGE 3-4 CHRONIC KIDNEY DISEASE.Tang, W., Chen, Q., Chen, L., et al.[2023]
L-Thyroxin Henning 100 demonstrated significantly higher bioavailability compared to Eferox 100, leading to higher free thyroxine (fT4) levels and a greater reduction in serum TSH levels after 14 days of treatment in a study involving 60 euthyroid volunteers.
The study suggests that when switching between different LT4 preparations, regular monitoring of serum TSH and fT4 levels is essential to prevent metabolic imbalances, as individual factors like gender and body weight can influence bioavailability.
[Randomized, double-blind crossover study of bioavailability of levothyroxine].Krehan, A., Dittmar, M., Hoppen, A., et al.[2019]

References

Prevention of progressive renal failure by levothyroxine sodium in a diabetic patient with renal insufficiency and hypothyroidism. [2019]
FAVORABLE EFFECT OF LEVOTHYROXINE ON NUTRITIONAL STATUS OF PATIENTS WITH STAGE 3-4 CHRONIC KIDNEY DISEASE. [2023]
[Randomized, double-blind crossover study of bioavailability of levothyroxine]. [2019]
Can levothyroxine treatment reduce urinary albumin excretion rate in patients with early type 2 diabetic nephropathy and subclinical hypothyroidism? A randomized double-blind and placebo-controlled study. [2018]
INTRAVENOUS LEVOTHYROXINE DURING HEMODIALYSIS IN A PATIENT WITH HYPOTHYROIDISM AND NON-ADHERENCE TO ORAL MEDICATIONS. [2022]
Drug interactions in users of tablet vs. oral liquid levothyroxine formulations: a real-world evidence study in primary care. [2019]
[Treatment of hypothyroidism]. [2013]
Optimizing treatment of hypothyroidism. [2019]
Liver dysfunction induced by Levothyroxine Sodium Tablets (Euthyrox®) in a hypothyroid patient with Hashimoto's thyroiditis: case report and literature review. [2020]
Center-specific variations of thyroid hormone serum levels in hemodialysis patients. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Changes in thyroxine requirements in patients with hypothyroidism undergoing renal transplantation. [2013]
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