Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism (HYPOCARE treat)

Lars Rejnmark

Status and phase: Enrolling; Phase 4

Conditions: Hypoparathyroidism Post-surgical

Treatments: Drug: Placebo; Drug: Indapamide 1.5 MG SR

Study type: Interventional

Funder types: Other

Identifiers

NCT07034677

CTIS 2024-516000-41-01

2024-516000-41-01 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The aim of this study is to investigate the effect of daily treatment with Indapamide for 14 days on urinary calcium excretion in patients with post surgical hypoparathyroidisme.

Full description

The aim of this study is to investigate the effect of daily treatment with Indapamide for 14 days on urinary calcium excretion in patients with post surgical hypoparathyroidisme.

Patients will do weekly blood sampling and 24 hour urine collection every second week.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chronic post surgical hypoparathyroidism diagnosed > 1 year ago
2. Age ≥ 18 years
3. Require treatment with active vitamin D ≥ 1 µg/day
4. Ionized plasma calcium between 1.15-1.25 mmol/L
5. 25(OH)D vitamin ≥ 50 nmol/L
6. Plasma magnesium > 0.65 mmol/L
7. Able to read and understand Danish
8. Willing and able to sign the informed consent form

Exclusion criteria

1. Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3

2. Active cancer or former (except thyroid and basal cell skin) cancer treatment < 1 year ago

3. Pregnancy, pregnancy plans, or breastfeeding < 1 year ago

4. Abnormal arterial pressure at time of screening defined as symptomatic hypotension or systolic blood pressure < 100 mmHg

5. Plasma potassium < 3.5 mmol/L

6. Any current disease that might affect the calcium metabolism such as but not limited to:

   1. Recent prolonged immobility
   2. Untreated diabetes (HbA1c > 53 mmol/mol)
   3. Severe liver disease or hepatic encephalopathy
   4. Untreated thyroid disease

7. Current disease that might affect gastrointestinal absorption

8. Use of medications such as lithium or diuretics within 4 weeks prior to start of treatment

9. Known allergy or sensitivity to Indapamide, its excipients or sulfonamides

10. Known galactosemia, lactase deficiency, or glucose-galactose malabsorption

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Indapamide

Active Comparator group

Description:

14 days with active drug Indapamide 1.5 mg/day

Treatment:

Drug: Indapamide 1.5 MG SR

Placebo

Placebo Comparator group

Description:

14 days with placebo

Treatment:

Drug: Placebo