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RecruitingNCT07034677HYPOCARE treatUpdated Aug 11, 2025

Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism

A Phase 4 interventional study of Indapamide 1.5 MG SR and Placebo in Hypoparathyroidism Post-surgical, sponsored by Lars Rejnmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Lars Rejnmark · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Hypoparathyroidism Post-surgical

Keywords

  • hypoparathyroidism
  • indapamide
  • hypercalciuria
03

In context

Hypoparathyroidism

128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.

Browse Hypoparathyroidism studies →

Lead sponsor

This is the only study on the registry with Lars Rejnmark as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

Exclusion Criteria:

  1. Estimated (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 ( > 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 or sulfonamides
  10. Known galactosemia, lactase deficiency, or glucose-galactose malabsorption
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Indapamide

    14 days with active drug Indapamide 1.5 mg/day

    Drug: Indapamide 1.5 MG SR

  • Placebo comparator
    Placebo

    14 days with placebo

    Drug: Placebo

Interventions

  • 14 days treatment with indapamide 1.5 mg/day compared to placebo

  • DrugPlacebo

    14 days treatment with placebo

06

What researchers measure

Primary outcomes

  1. Urinary calcium excretion

    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

    Time frame: Day 15

Secondary outcomes

  1. Ionized calcium

    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.

    Time frame: Day 15

  2. Sodium diet

    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

    Time frame: Day 15

  3. Safety (blood pressure)

    To assess the safety (blood pressure) of daily treatment with Indapamide for 14 days compared to placebo

    Time frame: Day 15

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Only IPD used in the results publication

Supporting information: Study protocol, Clinical study report

Time frame: start data is time of publication and end 5 years after publication

Access criteria: By contacting the leading author of the publication in order to make a data sharing agreement, which should be signed. Proposal for agreement must contain planned analyses. Statistical analyses have to be approved by independent review before published. Data sharing agreement needs to be approved by the Technology Transfer Office (TTO), Aarhus University Hospital, Denmark

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2025; primary completion for Dec 2025, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2025
First posted
Jun 24, 2025
StartEst.
Aug 2025
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Aug 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07034677
Lead sponsor
Lars Rejnmark
Responsible party
Lars Rejnmark (MD, Ph.D., DMSc, prof, University of Aarhus) — Sponsor-investigator
First posted
Jun 24, 2025
Start date
Aug 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 11, 2025

Study contacts

Sarah Thornhøj, MD
Contact
sarthorn@rm.dk
+4540491821

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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