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Recruiting Phase 4

Prednisolone Treatment in Acute Interstitial Nephritis

NCT04376216 · tracked via the Priya Life Science Denmark tracker
Sponsor
Region MidtJylland Denmark
Phase
Phase 4
Started
2017-09-01
Last updated
2020-12-30

Condition(s) studied

Acute Tubulo-Interstitial Nephritis

Investigational drug(s) / intervention(s)

Prednisone →

Prednisone: 60 mg with dose tapering over 2 months

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • eGFR — 3 months
    Kidney function

Trial sites (1)

FacilityCityRegionStatus
Godstrup Hospital Herning Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04376216 on ClinicalTrials.gov ↗ ← All trials in Denmark