Hypocare Treat

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

4 Jun 2025 → ongoing

Decision date (initial)

2025-02-26

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Aarhus University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Efficacy

To investigate the effect of daily treatment with Indapamide for 14 days compared to placebo on urinary calcium excretion in patients with chronic post-surgical hypoparathyroidism

Secondary objectives 3

1. To assess if treatment with Indapamide can affect the level of ionized calcium in the blood during treatment with Indapamide and hereby reduce the need for supplementation with oral calcium and active vitamin D.
2. To assess the efficacy of a low sodium diet in the placebo period on plasma ionized calcium and on the 24-hour urinary calcium excretion in patients with hypoparathyroidism
3. To assess the safety of daily treatment with Indapamide for 14 days compared to placebo

Conditions and MedDRA coding

Hypoparathyroidism

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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 10

1. Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3
2. Known galactosemia, lactase deficiency, or glucose-galactose malabsorption
3. Active cancer or former (except thyroid and basal cell skin) cancer treatment < 1 year ago
4. Pregnancy, pregnancy plans, or breastfeeding < 1 year ago
5. Abnormal arterial pressure at time of screening defined as symptomatic hypotension or systolic blood pressure < 100 mmHg
6. Plasma potassium < 3.5 mmol/L
7. 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
8. Current disease that might affect gastrointestinal absorption
9. Use of medications such as lithium or diuretics within 4 weeks prior to start of treatment
10. Known allergy or sensitivity to Indapamide, its excipients or sulfonamides

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Changes in 24-hour urinary calcium excretion after 14 days of treatment
2. Changes in 24-hour urinary calcium excretion after 7 days of treatment

Secondary endpoints 4

1. Changes in plasma ionized calcium after 7 and 14 days of treatment
2. Changes in supplementation with active vitamin D and oral calcium after 7 and 14 days of treatment
3. Changes in plasma ionized calcium in the placebo period due to a sodium restrictive diet
4. Changes in 24-hour urinary calcium excretion in the placebo period due to a sodium restrictive diet

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

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

Lars Rejnmark

Public contact point

Organisation

Region Midtjylland

Contact name

Lars Rejnmark

Third parties 3

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications