Trial | NCT04376216  Report issue

Title

Prednisolone Treatment in Acute Interstitial Nephritis
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    110
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
Study Started
Sep 01
2017
Primary Completion
Sep 01
2026
Anticipated
Study Completion
Sep 01
2027
Anticipated
Last Update
Dec 30
2020

Drug Prednisone

60 mg with dose tapering over 2 months

  • Other names: Prednisolone

Control No Intervention

No treatment

Prednisone Active Comparator

Oral prednisone. Starting dose of 60 mg with tapering for 2 months

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted