Prednisone treatment in acute interstitial nephritis (PRAISE)

Phase 4

Not yet recruiting

• Conditions: Acute interstitial nephritis

• Registration Number: 2024-520299-86-00
• Lead Sponsor: Region Midtjylland

Brief Summary

To investigate the effect of prednisolone treatment in acute interstitial nephritis.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Biopsi proven acute interstitial nephritis (AIN), Clinical suspision of AIN, Age of minimum 18 years, One of the two following criteria: Creatinine > 120 mmol/l or Creatinine increase of > 30 mmol/l or 1,5 x creatinine-increase, Women with child bearing potential

Exclusion Criteria

• Not able to give consent. • IImmunosuppressive therapy within 3 months • Autoimmune disease. • Allergy or intolerance towards MP eller prednisolone. • Pregnancy or nursing • Active cancer except basal celle carcinoma. • Terminal illness with life expectancy of less than 6 months • CKD 4 or 5 • Previous participation • AIN associated with glomerulonefritis, sarcoidosis eller inherited interstitial kidney diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eGFR at 3 months		eGFR at 3 months

Secondary Outcome Measures

Name	Time	Method
Kidney function (eGFR) at 12 months, CKD stage, Number og patients in dialysis, Effekt of treatment-delay on outcome, Urinary biomarkers, Questionaire: SF36 score, The predictive value of histopathological evaluation, Safety endpoints: P-glukose, Infections, Submissions		Kidney function (eGFR) at 12 months, CKD stage, Number og patients in dialysis, Effekt of treatment-delay on outcome, Urinary biomarkers, Questionaire: SF36 score, The predictive value of histopathological evaluation, Safety endpoints: P-glukose, Infections, Submissions

Trial Locations

Locations (9)

Copenhagen University Hospital; 🇩🇰 Herlev, Denmark

Rigshospitalet; 🇩🇰 Copenhagen Oe, Denmark

Lillebaelt Hospital; 🇩🇰 Kolding, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark

Region Midtjylland; 🇩🇰 Viborg, Denmark

Region Syddanmark; 🇩🇰 Aabenraa, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Nordsjaellands Hospital; 🇩🇰 Hilleroed, Denmark

Copenhagen University Hospital

🇩🇰Herlev, Denmark

Anja Jensen

Site contact

46323200

amoj@regionsjaelland.dk

Bo Broberg

Site contact

38683868

bo.broberg@regionh.dk