Overview
Sponsor-declared trial summary
Hypomagnesemia due to HNF1beta mutation
To evaluate the effect of SGLT2 inhibition with dapagliflozin 10mg on serum magnesium in diabetic and non-diabetic patients with HNF1beta-associated renal hypomagnesemia
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- completed 1 May 2025
- Decision date (initial)
- 2024-11-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518855-43-00
- EudraCT number
- 2022-000596-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the effect of SGLT2 inhibition with dapagliflozin 10mg on serum magnesium in diabetic and non-diabetic patients with HNF1beta-associated renal hypomagnesemia
Conditions and MedDRA coding
Hypomagnesemia due to HNF1beta mutation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Genetically proven HNF1beta disease
- Renal hypomagnesemia (serum magnesium < 0.70 mmol/l)
- Age 18 - 75 years
- Informed consent
Exclusion criteria 8
- All other types of diabetes mellitus, including type 1 and type 2 diabetes
- History of kidney transplantation
- Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
- Previous intolerance for an SGLT2 inhibitor
- Pregnancy or lactation
- Use of loop diuretics of thiazide diuretics and inability to discontinue these medications before start of the trial
- eGFR < 30ml/min/1,73m2
- Patient with severe hepatic impairment (Child-Pugh class C)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in serum magnesium
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB31650 · Substance
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Maartje Verploegen
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Maartje Verploegen
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Research_protocol_DAPA-MAG | 4 |
| Recruitment arrangements (for publication) | K1_blank_document_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_Subject_information_informed_consent_form | 5 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Netherlands | Acceptable 2024-11-22
|
2024-11-22 |