Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
110
Countries
1
Sites
11
Acute interstitial nephritis
To investigate the effect of prednisolone treatment in acute interstitial nephritis.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune System Phenomena [G13], Diseases [C] - Immune System Diseases [C20], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 22 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Augustinus Foundation · Lægeforeningen · Regionshospitalet Gødstrup · Region Midtjylland
External identifiers
- EU CT number
- 2024-520299-86-00
- EudraCT number
- 2017-000992-10
- ClinicalTrials.gov
- NCT04376216
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To investigate the effect of prednisolone treatment in acute interstitial nephritis.
Secondary objectives 1
- As above
Conditions and MedDRA coding
Acute interstitial nephritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10029135 | Nephritis interstitial acute | 10038359 |
| 21.1 | PT | 10048302 | Tubulointerstitial nephritis | 100000004857 |
| 21.1 | LLT | 10022614 | Interstitial nephritis acute | 10038359 |
| 21.1 | LLT | 10000819 | Acute interstitial nephritis | 10038359 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518491-31-00 | Prednisone treatment in acute interstitial nephritis - a randomized prospective trial (PRAISE) | Region Midtjylland |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Biopsi proven acute interstitial nephritis (AIN), Clinical suspision of AIN, Age of minimum 18 years, One of the two following criteria: Creatinine > 120 mmol/l or Creatinine increase of > 30 mmol/l or 1,5 x creatinine-increase, Women with child bearing potential
Exclusion criteria 1
- • Not able to give consent. • IImmunosuppressive therapy within 3 months • Autoimmune disease. • Allergy or intolerance towards MP eller prednisolone. • Pregnancy or nursing • Active cancer except basal celle carcinoma. • Terminal illness with life expectancy of less than 6 months • CKD 4 or 5 • Previous participation • AIN associated with glomerulonefritis, sarcoidosis eller inherited interstitial kidney diseases
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- eGFR at 3 months
Secondary endpoints 1
- Kidney function (eGFR) at 12 months, CKD stage, Number og patients in dialysis, Effekt of treatment-delay on outcome, Urinary biomarkers, Questionaire: SF36 score, The predictive value of histopathological evaluation, Safety endpoints: P-glukose, Infections, Submissions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10683477 · Product
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 2000 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- 08386
- MA holder
- ORIFARM HEALTHCARE A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10683476 · Product
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 2000 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- 07772
- MA holder
- ORIFARM HEALTHCARE A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Hospitalsparken 15
- City
- Herning
- Postcode
- 7400
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Jesper Nørgaard Bech
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Jesper Nørgaard Bech
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 110 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Copenhagen University Hospital
Nyremedicinsk afdeling, Kogevej 7, 4000, Roskilde
Rigshospitalet
Nyremedicinsk afdeling, Blegdamsvej 9, 2100, Copenhagen Oe
Lillebaelt Hospital
Medicinsk afdeling, Sygehusvej 24, 6000, Kolding
Odense University Hospital
Nyremedicinsk afdeling, J B Winsloews Vej 4, 5000, Odense C
Region Midtjylland
Medicinsk afdeling, Heibergs Alle 5a, 8800, Viborg
Copenhagen University Hospital
Nyremedicinsk afdeling, Ringvej 75, 2730, Herlev
Region Syddanmark
Nyremedicinsk afdeling, Gl Vardevej 101, 6715, Esbjerg N
Aalborg University Hospital
Nyremedicinsk afdeling, Hobrovej 18-22, 9000, Aalborg
Aarhus University Hospital
Nyremedicinsk afdeling, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Nordsjaellands Hospital
Kardiologisk, Nefrologisk og Endokrinologisk afdeling, Dyrehavevej 29, 3400, Hilleroed
Region Syddanmark
Medicinsk afdeling, Kresten Philipsens Vej 15, 6200, Aabenraa
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 | 2025-01-22 | 2025-01-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PRAISEv403092024 | 1 |
| Recruitment arrangements (for publication) | Placeholder til CTIS ansgning | 1 |
| Subject information and informed consent form (for publication) | AINdeltagerinformation7_1 | 1 |
| Subject information and informed consent form (for publication) | AINSamtykkeerklring | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Prednison DAK tabletter 5 mg og 25 mg | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-16 | Denmark | Acceptable 2025-01-13
|
2025-01-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-10 | Denmark | Acceptable 2025-01-13
|
2025-10-10 |