Overview
Sponsor-declared trial summary
Nephrogenic diabetes insipidus
The overall aim is to improve quality of life and relieve of the severe impairment associated with NDI in patients. This is achieved by testing if the antifungal drug fluconazole can reduce diuresis and improve the urinary concentration ability in patients with nephrogenic diabetes insipidus due to an AVPR2 gene mutati…
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 12 Sep 2024 → 19 Feb 2026
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517438-16-00
- EudraCT number
- 2020-002204-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The overall aim is to improve quality of life and relieve of the severe impairment associated with NDI in patients. This is achieved by testing if the antifungal drug fluconazole can reduce diuresis and improve the urinary concentration ability in patients with nephrogenic diabetes insipidus due to an AVPR2 gene mutation.
Conditions and MedDRA coding
Nephrogenic diabetes insipidus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10068304 | Congenital nephrogenic diabetes insipidus | 100000004850 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male
- Age > 18 year
- Mentally capable of understanding the test
- Nephrogenic diabetes insipidus diagnosed by genetic defect in AVPR2
Exclusion criteria 4
- Other known relevant disease including malignity
- Contraindications to fluconazole
- Prolonged QT interval on baseline ECG
- Concurrent treatment with drugs metabolized by CYP3A4, CYP2C19 or CYP2C9
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Spontaneous urinary volume and urinary concentration ability (osmolality).
Secondary endpoints 1
- Plasma osmolality, abundance of AQP2 in urinary exosomes, plasma vasopressin/copeptin concentrations, plasma electrolytes, micturition frequency
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1086356 · ATC
- Active substance
- Clotrimazole
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Gitte Rye Hinrichs
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Gitte Rye Hinrichs
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-09-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 6 |
| Recruitment arrangements (for publication) | Recruitement procedures | 2 |
| Subject information and informed consent form (for publication) | Informed concent form | 1 |
| Subject information and informed consent form (for publication) | Subject Information version 4 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SMPC_produktresume_fluconazol | 1 |
| Synopsis of the protocol (for publication) | Protokolresume | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-23 | Denmark | Acceptable 2024-09-12
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-11 | Denmark | Acceptable 2025-12-08
|
2025-12-09 |