Prednisolone Treatment in Acute Interstitial Nephritis
PRAISE
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
1 other identifier
interventional
110
1 country
1
Brief Summary
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
December 30, 2020
December 1, 2020
9 years
April 27, 2020
December 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
eGFR
Kidney function
3 months
Secondary Outcomes (8)
eGFR
12 months
Urinary biomarkers
at inclusion and after3 and 12 months
Pathology
At inclusion
Need for renal replacement therapy
3 and 12 months
Plasma glucose or hemoglobin A1C
3 and 12 months
- +3 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONNo treatment
Prednisone
ACTIVE COMPARATOROral prednisone. Starting dose of 60 mg with tapering for 2 months
Interventions
Eligibility Criteria
You may qualify if:
- Biopsy verified AIN
- 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
You may not qualify if:
- No ability to give informed consent
- 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
- Withdrawal of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region MidtJylland Denmarklead
- Aarhus University Hospitalcollaborator
- Odense University Hospitalcollaborator
Study Sites (1)
Godstrup Hospital
Herning, 7400, Denmark
Related Publications (1)
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.
PMID: 33933012DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jesper N Bech, MD
Region MidtJylland Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 27, 2020
First Posted
May 6, 2020
Study Start
September 1, 2017
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
December 30, 2020
Record last verified: 2020-12