Prednisolone Treatment in Acute Interstitial Nephritis

Last updated: December 29, 2020
Sponsor: Region MidtJylland Denmark
Overall Status: Active - Recruiting

Phase

4

Condition

Nephritis

Treatment

N/A

Clinical Study ID

NCT04376216
FHM-1-2017
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis

Eligibility Criteria

Inclusion

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 plasmacreatinine
  • Fertile women are included

Exclusion

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 inheritedinterstitial renal disease
  • Previous participation Withdrawal criteria
  • Development of exclusion criterion
  • Withdrawal of consent

Study Design

Total Participants: 110
Study Start date:
September 01, 2017
Estimated Completion Date:
September 01, 2027

Connect with a study center

  • Godstrup Hospital

    Herning, 7400
    Denmark

    Active - Recruiting

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