INDAPAMIDE HEMIHYDRATE for Post-surgical hypoparathyroidism|Hypoparathyroidism

Inclusion criteria

• {"criterion_text":"- Chronic post surgical hypoparathyroidism diagnosed > 1 year ago\n- Age ≥ 18 years\n- Require treatment with active vitamin D ≥ 1 µg/day\n- Ionized plasma calcium between 1.15-1.25 mmol/L\n- 25(OH)D vitamin ≥ 50 nmol/L\n- Plasma magnesium > 0.65 mmol/L\n- Able to read and understand Danish\n- Willing and able to sign the informed consent form"}

Exclusion criteria

• {"criterion_text":"- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3\n- Known allergy or sensitivity to Indapamide, its excipients or sulfonamides\n- Known galactosemia, lactase deficiency, or glucose-galactose malabsorption\n- Active cancer or former (except thyroid and basal cell skin) cancer treatment < 1 year ago\n- Pregnancy, pregnancy plans, or breastfeeding < 1 year ago\n- Abnormal arterial pressure at time of screening defined as symptomatic hypotension or systolic blood pressure < 100 mmHg\n- Plasma potassium < 3.5 mmol/L\n- Any current disease that might affect the calcium metabolism such as but not limited to: Recent prolonged immobility, untreated diabetes (HbA1c > 53 mmol/mol), severe liver disease or hepatic encephalopathy, untreated thyroid disease\n- Current disease that might affect gastrointestinal absorption\n- Use of medications such as lithium or diuretics within 4 weeks prior to start of treatment"}

Primary endpoints

• {"endpoint_text":"- Changes in 24-hour urinary calcium excretion after 14 days of treatment\n- Changes in 24-hour urinary calcium excretion after 7 days of treatment","definition_or_measurement_approach":"Change in 24-hour urinary calcium excretion measured after 7 days and after 14 days of treatment (24-hour urine collection)."}

Secondary endpoints

• {"endpoint_text":"- Changes in plasma ionized calcium after 7 and 14 days of treatment\n- Changes in supplementation with active vitamin D and oral calcium after 7 and 14 days of treatment\n- Changes in plasma ionized calcium in the placebo period due to a sodium restrictive diet\n- Changes in 24-hour urinary calcium excretion in the placebo period due to a sodium restrictive diet","definition_or_measurement_approach":"Measurements include plasma ionized calcium at days 7 and 14, assessment of changes in supplementation with active vitamin D and oral calcium (use/amount) at days 7 and 14, and assessment of plasma ionized calcium and 24-hour urinary calcium excretion during the placebo period with a sodium-restrictive diet (24-hour urine collection and plasma ionized calcium measurements)."}

Denmark

Earliest CTIS Part Ii Submission Date

19-02-2025

Latest Decision Or Authorization Date

26-02-2025

Processing Time Days

7

Number Of Sites

1

Number Of Participants

24

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]; contact email: gcp@clin.au.dk","organisation_type":"Educational Institution"}
• {"country":"Denmark","full_name":"Dep. of Clinical Biochemistry","duties_or_roles":"sponsorDuties codes: [4]; contact email: biokemi@auh.rm.dk","organisation_type":"Health care"}
• {"country":"Denmark","full_name":"Regionsapoteket Midtjylland","duties_or_roles":"sponsorDuties codes: [14]; contact email: hospitalsapoteket@auh.rm.dk","organisation_type":"Health care"}