Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
110 participants
INTERVENTIONAL
2017-09-01
2027-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
No treatment
No interventions assigned to this group
Prednisone
Oral prednisone. Starting dose of 60 mg with tapering for 2 months
Prednisone
60 mg with dose tapering over 2 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prednisone
60 mg with dose tapering over 2 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical suspicion of AIN
* Age \> 18 years
* One of following criteria:
* Plasma creatinine \> 120 µmol/L or
* Plasma creatinine increase \> 30 µmol/L or increase \> 50 % of baseline plasma creatinine
* Fertile women are included
Exclusion Criteria
* Immunosuppressive treatment (including prednisolone) within 3 months before biopsy
* Autoimmune disease
* Prednisolone intolerance
* Pregnancy or lactation
* Active cancer (except basal cell carcinoma)
* Short life expectancy (\< 6 months)
* CKD stage IV-V
* AIN secondary to or accompanied by glomerulonephritis, sarcoidosis or inherited interstitial renal disease
* Previous participation Withdrawal criteria
* Development of exclusion criterion
* Withdrawal of consent
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
Region MidtJylland Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Frank Mose
Associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jesper N Bech, MD
Role: STUDY_CHAIR
Region MidtJylland Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Godstrup Hospital
Herning, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Frank Mose
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Mose FH, Birn H, Hoffmann-Petersen N, Bech JN. Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial. BMC Nephrol. 2021 May 1;22(1):161. doi: 10.1186/s12882-021-02372-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FHM-1-2017
Identifier Type: -
Identifier Source: org_study_id