Overview
Sponsor-declared trial summary
Hypothyroidism
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
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 12 Mar 2026 → ongoing
- Decision date (initial)
- 2026-03-03
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
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
Secondary objectives 3
- To assess the effect of early LT4 initiation on thyroid hormone levels (TSH, T4, and T3).
- To assess changes in HRQoL measured by the ThyPRO-39 questionnaire.
- To evaluate changes in body weight and body mass index (BMI).
Conditions and MedDRA coding
Hypothyroidism
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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.
Exclusion criteria 12
- Previous thyroid operation
- Planned total thyroidectomy or completion thyroidectomy during follow-up
- Treatment with Thycapzole or similar medication with direct effect on thyroid hormones.
- Concomitant operation for primary hyperparathyroidism (PHPT).
- Pregnancy or plans of pregnancy in the postoperative period.
- Cancer treatment within the last three years.
- Use of narcotics or alcohol abuse.
- Severe other illness (psychiatric disorder, kidney disease with GFR < 30 etc.).
- Severe cardio-vascular disease (atrial fibrillation, heart failure etc.).
- Initiated treatment with either ACE inhibitors, ARB or SGLT2 after surgery.
- Inability to understand Danish or provide informed consent.
- Participation in another interventional study that may interfere with outcomes.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change eGFR from baseline to 3 months postoperatively, measured in mL/min/1.73m² using standard laboratory methods.
Secondary endpoints 4
- Serum levels of TSH, T4, and T3 at 3 months postoperatively.
- ThyPRO-39 composite score changes from baseline to 3 and 6 months postoperatively.
- Change in body weight (kg) and BMI (kg/m²) from baseline to 3 months and 6 months.
- In control group participants who initiate THRT at 3 months due to elevated TSH (>1.5 mIU/L), follow-up changes in eGFR and HRQoL at 6 months.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SCP108721542 · ATC
- Active substance
- Levothyroxine
- Substance synonyms
- L-THYROXINE
- Route of administration
- ORAL
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 18200 µg microgram(s)
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- H03AA01 — LEVOTHYROXINE SODIUM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02917MIG · Substance
- Active substance
- Levothyroxine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 270 µg microgram(s)
- Max total dose
- 49000 µg microgram(s)
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02917MIG · Substance
- Active substance
- Levothyroxine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 270 µg microgram(s)
- Max total dose
- 49000 µg microgram(s)
- Max treatment duration
- 28 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Mathilde Lykke Seekjær
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Mathilde Lykke Seekjær
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 56 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-03-12 | 2026-03-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D4 _Patient facing documents_questionnaire | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Euthyrox | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol 2025-524175-23-00 V2 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol 2025-524175-23-00_version 1 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-07 | Denmark | Acceptable 2026-02-13
|
2026-03-03 |