2025-524175-23-00RecruitingPhase 4
Impact of Early Thyroid Hormone Replacement on Kidney Function and Health-Related Quality of Life in Patients at Risk of Postoperative Hypothyroidism after Hemithyroidectomy: A Randomised Controlled Trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Mar 2026
Brief summary (registry, in English)
To evaluate whether postoperative treatment with LT4 leads to an improvement in kidney function - measured as change in eGFR - three months after HT, compared to standard care without LT4
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 7 Nov 2025
- Start date
- 12 Mar 2026
- Lead sponsor
- Region Midtjylland
- Diseases
- Chronic kidney disease
- EU CT number
- 2025-524175-23-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 56
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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 who are about to have their first hemithyroidectomy (removal of half of the thyroid gland) and have a TSH of at least 2 mUI/L. It tests early thyroid hormone (LT4) treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Referred for a first hemithyroidectomy, with a TSH of 2 mUI/L or higher and eGFR (a kidney function test) above 30 mL/min/1.73m2
- Earlier treatment
- No previous thyroid operation. Treatment with ACE inhibitors, ARB or SGLT2 must not be started after surgery. No cancer treatment in the last three years.
- Biomarker or test result
- TSH 2 mUI/L or higher; eGFR above 30 mL/min/1.73m2
Main reasons for not taking part
- A previous thyroid operation
- A planned total thyroidectomy or completion thyroidectomy during follow-up
- Pregnancy or plans of pregnancy after the operation
- Cancer treatment within the last three years
- Severe other illness, including severe heart disease or kidney disease with GFR below 30
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous thyroid operation
- Initiated treatment with either ACE inhibitors, ARB or SGLT2 after surgery.
- Treatment with Thycapzole or similar medication with direct effect on thyroid hormones.
- Concomitant operation for primary hyperparathyroidism (PHPT).
Other illness
- Cancer treatment within the last three years.
- Severe cardio-vascular disease (atrial fibrillation, heart failure etc.).
Lab values
- Severe other illness (psychiatric disorder, kidney disease with GFR < 30 etc.).
Other
- Inability to understand Danish or provide informed consent.
- Participation in another interventional study that may interfere with outcomes.
- Planned total thyroidectomy or completion thyroidectomy during follow-up
- Pregnancy or plans of pregnancy in the postoperative period.
- Use of narcotics or alcohol abuse.
Who the study is looking for
- Patients referred for a first hemithyroidectomy
- TSH ≥2 mUI/L.
- eGFR > 30 mL/min/1.73m2.
- Age 18 years or above
- Ability to understand the study information and provide written informed consent.
- Able and willing to comply with study procedures and attend scheduled visits.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland | Aarhus N | Denmark | Recruiting |
| Region Midtjylland | Herning | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.