Status:
RECRUITING
Prednisolone Treatment in Acute Interstitial Nephritis
Lead Sponsor:
Region MidtJylland Denmark
Collaborating Sponsors:
Aarhus University Hospital
Odense University Hospital
Conditions:
Acute Tubulo-Interstitial Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Development of exclusion criterion
- Withdrawal of consent
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04376216
Start Date
September 1 2017
End Date
September 1 2027
Last Update
December 30 2020
Active Locations (1)
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1
Godstrup Hospital
Herning, Denmark, 7400