Clinical trial • Phase IV • Immunology|Nephrology
PREDNISOLONE for Acute interstitial nephritis|Tubulointerstitial nephritis
Phase IV trial of PREDNISOLONE for Acute interstitial nephritis|Tubulointerstitial nephritis. Randomised. 110 participants.
Overview
- Trial Therapeutic Area
- Immunology|Nephrology
- Trial Disease
- Acute interstitial nephritis|Tubulointerstitial nephritis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-12-2024
- First CTIS Authorization Date
- 13-01-2025
Trial design
Randomised Phase IV trial across 11 sites in Denmark.
- Randomised
- Yes
- Target Sample Size
- 110
- Trial Duration For Participant
- 365
Eligibility
Recruits 110 Vulnerable populations not selected. Persons "Not able to give consent" are excluded. Informed consent required; subject information and informed consent form documents are listed in the trial documents..
- Pregnancy Exclusion
- Pregnancy or nursing
- Vulnerable Population
- Vulnerable populations not selected. Persons "Not able to give consent" are excluded. Informed consent required; subject information and informed consent form documents are listed in the trial documents.
Inclusion criteria
- {"criterion_text":"- Biopsi proven acute interstitial nephritis (AIN)\n- Clinical suspision of AIN\n- Age of minimum 18 years\n- One of the two following criteria: Creatinine > 120 mmol/l or Creatinine increase of > 30 mmol/l or 1,5 x creatinine-increase\n- Women with child bearing potential"}
Exclusion criteria
- {"criterion_text":"- • Not able to give consent.\n- • IImmunosuppressive therapy within 3 months\n- • Autoimmune disease.\n- • Allergy or intolerance towards MP eller prednisolone.\n- • Pregnancy or nursing\n- • Active cancer except basal celle carcinoma.\n- • Terminal illness with life expectancy of less than 6 months\n- • CKD 4 or 5\n- • Previous participation\n- • AIN associated with glomerulonefritis, sarcoidosis eller inherited interstitial kidney diseases"}
Endpoints
Primary endpoints
- {"endpoint_text":"- eGFR at 3 months","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Kidney function (eGFR) at 12 months\n- CKD stage\n- Number og patients in dialysis\n- Effekt of treatment-delay on outcome\n- Urinary biomarkers\n- Questionaire: SF36 score\n- The predictive value of histopathological evaluation\n- Safety endpoints: P-glukose, Infections, Submissions","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 179
- Consent Approach
- Informed consent required from participants. Persons unable to give consent are excluded ("Not able to give consent."). Subject information and informed consent form documents are provided (document titles include AINdeltagerinformation7_1 and AINSamtykkeerklring). No details provided about assent or age-specific consent documents or languages.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 110
Denmark
- Earliest CTIS Part Ii Submission Date
- 06-01-2025
- Latest Decision Or Authorization Date
- 10-10-2025
- Processing Time Days
- 277
- Number Of Sites
- 11
- Number Of Participants
- 110
Sites
- Site Name
- Copenhagen University Hospital
- Department Name
- Nyremedicinsk afdeling
- Principal Investigator Name
- Bo Broberg
- Principal Investigator Email
- bo.broberg@regionh.dk
- Contact Person Name
- Bo Broberg
- Contact Person Email
- bo.broberg@regionh.dk
- Site Name
- Lillebaelt Hospital
- Department Name
- Medicinsk afdeling
- Principal Investigator Name
- Rikke Juul-Sandberg
- Principal Investigator Email
- rikke.juul-sandberg@rsyd.dk
- Contact Person Name
- Rikke Juul-Sandberg
- Contact Person Email
- rikke.juul-sandberg@rsyd.dk
- Site Name
- Aarhus University Hospital
- Department Name
- Nyremedicinsk afdeling
- Principal Investigator Name
- Henrik Birn
- Principal Investigator Email
- HENBIR@rm.dk
- Contact Person Name
- Henrik Birn
- Contact Person Email
- HENBIR@rm.dk
- Site Name
- Nordsjaellands Hospital
- Department Name
- Kardiologisk, Nefrologisk og Endokrinologisk afdeling
- Principal Investigator Name
- Christian Arndt
- Principal Investigator Email
- christian.guldbjerg.arndt@regionh.dk
- Contact Person Name
- Christian Arndt
- Contact Person Email
- christian.guldbjerg.arndt@regionh.dk
- Site Name
- Region Syddanmark
- Department Name
- Nyremedicinsk afdeling
- Principal Investigator Name
- Karin Østergaard
- Principal Investigator Email
- karin.brochner.ostergaard@rsyd.dk
- Contact Person Name
- Karin Østergaard
- Contact Person Email
- karin.brochner.ostergaard@rsyd.dk
- Site Name
- Copenhagen University Hospital
- Department Name
- Nyremedicinsk afdeling
- Principal Investigator Name
- Anja Jensen
- Principal Investigator Email
- amoj@regionsjaelland.dk
- Contact Person Name
- Anja Jensen
- Contact Person Email
- amoj@regionsjaelland.dk
- Site Name
- Region Midtjylland
- Department Name
- Medicinsk afdeling
- Principal Investigator Name
- Else Randers
- Principal Investigator Email
- elsran@rm.dk
- Contact Person Name
- Else Randers
- Contact Person Email
- elsran@rm.dk
- Site Name
- Region Syddanmark
- Department Name
- Medicinsk afdeling
- Principal Investigator Name
- Jan Kampmann
- Principal Investigator Email
- jan.dominik.kampmann1@rsyd.dk
- Contact Person Name
- Jan Kampmann
- Contact Person Email
- jan.dominik.kampmann1@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Nyremedicinsk afdeling
- Principal Investigator Name
- Martin Egfjord
- Principal Investigator Email
- martin.egfjord@regionh.dk
- Contact Person Name
- Martin Egfjord
- Contact Person Email
- martin.egfjord@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Nyremedicinsk afdeling
- Principal Investigator Name
- Jon Gregersen
- Principal Investigator Email
- jon.gregersen@rn.dk
- Contact Person Name
- Jon Gregersen
- Contact Person Email
- jon.gregersen@rn.dk
- Site Name
- Odense University Hospital
- Department Name
- Nyremedicinsk afdeling
- Principal Investigator Name
- Ann Maria Gramkow
- Principal Investigator Email
- ann-maria.lutzner.gramkow2@rsyd.dk
- Contact Person Name
- Ann Maria Gramkow
- Contact Person Email
- ann-maria.lutzner.gramkow2@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"Sponsor duty code: 1","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- Prednisolon "DAK", tabletter (PRD10683477)
- Active Substance
- PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation number 08386)
- Maximum Dose
- 80 mg (max daily dose)
- Investigational Product Name
- Prednisolon "DAK", tabletter (PRD10683476)
- Active Substance
- PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation number 07772)
- Maximum Dose
- 80 mg (max daily dose)
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