Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
Paraffin Oil Induced Granulomatous Disease
The main objective is to determine whether treatment with empagliflozin or losartan can reduce the risk of kidney stones and disease progression in patients with paraffin induced granulomas.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Hormonal diseases [C19], Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2026-05-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The main objective is to determine whether treatment with empagliflozin or losartan can reduce the risk of kidney stones and disease progression in patients with paraffin induced granulomas.
Conditions and MedDRA coding
Paraffin Oil Induced Granulomatous Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10033789 | Paraffinoma formation | 10018065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Signed informed consent by participant
- Male
- 18-70 years
- Paraffin granuloma disease with hypercalcemia, hypoparathyroidism, hypercalciuria or a history of nephrolithiasis
Exclusion criteria 8
- eGFR < 20 ml/min
- Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator’s opinion could interfere with the results of the trial
- Type 1 DM
- Known autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
- History of organ transplantation
- Receiving therapy with an SGLT2 inhibitor or ATII antagonist within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor or ATII antagonist.
- Known history of angioedema
- Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the trial, as judged by the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Image verified new or increased nephrolithiasis or nephrocalcinosis (from 1-24 months).
Secondary endpoints 15
- Change in estimated glomerular filtration rate (eGFR).
- Change in calcium homeostasis after 12 and 24 months defined by: 1A Change in p-Calcium ion concentration; 1B Change in p-PTH concentration; 1C Change in urine calcium excretion.
- Change in average daily prednisolone dosage based on cumulative average predniso-lone dose.
- Change in p-creatinine, eGFR and BUN.
- Change in p-IL-2R and/or p-ACE.
- Change in physical- and mental health scores (SF-36).
- Change in mineral homeostasis in serum and urine (albumin, phosphate, magnesium, iron, ferritin, FGF23, Klotho).
- Changes in serum vitamin D metabolites (25OHD,24,25(OH)2D3, 1,25(OH)2D).
- Change in urine Na, Ka, pH, citrate, oxalate, bicarbonate, uric acid, urea.
- Changes in left ventricular ejection fraction (LVEF) and other indices of cardiac func-tion as measured by transthoracic echocardiography.
- Incident or worsening signs of: Systolic- and/or diastolic dysfunction, left ventricular hypertrophy, structural heart disease including valvular pathology.
- Changes in CT Hounsfield Units in the femoral neck and lumbar vertebrae.
- Changes Coronary Artery Calcium Score on CT-scan.
- Change in BMD, fat- and lean mass evaluated by DXA-scan.
- Changes in self-reported kidney stones
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP1083046 · ATC
- Active substance
- Losartan Potassium
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 73000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09CA01 — LOSARTAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP150002022 · ATC
- Active substance
- Empagliflozin
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 18250 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — EMPAGLIFLOZIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Martin Blomberg Jensen
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Martin Blomberg Jensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Region Hovedstaden ORG-100003705
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 100 | 1 |
| 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 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2026-525608-85 | 5 |
| Protocol (for publication) | D1_Protocol_2026-525608-85_track_changes | 5 |
| Protocol (for publication) | D4_Patient facing documents SF-36 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_track_changes | 4 |
| Subject information and informed consent form (for publication) | L1_ICF | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_apendix | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_apendix_v3_track_changes | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_v3_track_changes | 3 |
| Subject information and informed consent form (for publication) | L1_SIS | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_track_changes | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Jardiance | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Losartan | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2026-525608-85 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2026-525608-85__TC | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-10 | Denmark | Acceptable 2026-05-11
|
2026-05-11 |