LEVOTHYROXINE for Hypothyroidism | Incident Kidney Dysfunction | Chronic Kidney Disease

Inclusion criteria

• {"criterion_text":"- Patients referred for a first hemithyroidectomy\n- TSH ≥2 mUI/L.\n- eGFR > 30 mL/min/1.73m2.\n- Age 18 years or above\n- Ability to understand the study information and provide written informed consent.\n- Able and willing to comply with study procedures and attend scheduled visits."}

Exclusion criteria

• {"criterion_text":"- Previous thyroid operation\n- Initiated treatment with either ACE inhibitors, ARB or SGLT2 after surgery.\n- Inability to understand Danish or provide informed consent.\n- Participation in another interventional study that may interfere with outcomes.\n- Planned total thyroidectomy or completion thyroidectomy during follow-up\n- Treatment with Thycapzole or similar medication with direct effect on thyroid hormones.\n- Concomitant operation for primary hyperparathyroidism (PHPT).\n- Pregnancy or plans of pregnancy in the postoperative period.\n- Cancer treatment within the last three years.\n- Use of narcotics or alcohol abuse.\n- Severe other illness (psychiatric disorder, kidney disease with GFR < 30 etc.).\n- Severe cardio-vascular disease (atrial fibrillation, heart failure etc.)."}

Primary endpoints

• {"endpoint_text":"- Change eGFR from baseline to 3 months postoperatively, measured in mL/min/1.73m² using standard laboratory methods.","definition_or_measurement_approach":"Measured in mL/min/1.73m² using standard laboratory methods; change from baseline to 3 months postoperative."}

Secondary endpoints

• {"endpoint_text":"- Serum levels of TSH, T4, and T3 at 3 months postoperatively.","definition_or_measurement_approach":"Serum measurements of TSH, T4 and T3 at 3 months postoperative (standard laboratory assays)."}
• {"endpoint_text":"- ThyPRO-39 composite score changes from baseline to 3 and 6 months postoperatively.","definition_or_measurement_approach":"Health-related quality of life measured by ThyPRO-39 composite score at baseline, 3 months and 6 months."}
• {"endpoint_text":"- Change in body weight (kg) and BMI (kg/m²) from baseline to 3 months and 6 months.","definition_or_measurement_approach":"Measured body weight (kg) and calculated BMI (kg/m²) at baseline, 3 months and 6 months."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Subgroup analysis of control participants initiating thyroid hormone replacement therapy at 3 months (TSH >1.5 mIU/L) with eGFR and HRQoL assessments at 6 months."}

Denmark

Earliest CTIS Part Ii Submission Date

12-02-2026

Latest Decision Or Authorization Date

03-03-2026

Processing Time Days

19

Number Of Sites

2

Number Of Participants

56

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: 1, 8","organisation_type":"Educational Institution"}