Prednisolone treatment in acute interstitial nephritis

Prednisolone treatment in acute interstitial nephritis - PRAISE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000992-10-DK

Enrollment

110

Registered

2017-04-28

Start date

2017-06-28

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute interstitial nephritis MedDRA version: 21.1 Level: PT Classification code 10048302 Term: Tubulointerstitial nephritis System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: LLT Classification code 10000819 Term: Acute interstitial nephritis System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: LLT Classification code 10022614 Term: Interstitial nephritis acute System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Prednisolone Product Name: Prednisolone Pharmaceutical Form: Tablet CAS Number: 125-02-0 Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Biopsi proven acute interstitial nephritis (AIN). • Clinical suspision of AIN • Age of minimum 18 years. • one of the two following criteria o Creatinine > 120 m?mol/l or o Creatinine increase of > 30 mmol/l or r 1,5 x creatinine-increase • Women with child bearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of prednisolone treatment in acute interstitial nephritis.;Secondary Objective: as above;Primary end point(s): oeGFR at 3 months;Timepoint(s) of evaluation of this end point: 3 months	—

Secondary

Measure	Time frame
Secondary end point(s): Kidney function 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 ;Timepoint(s) of evaluation of this end point: Primarily at3 and 12 months And continous measurements	—

Countries

Denmark

Contacts

Public ContactHospitalsenheden Vest

Universitets klinik for nyresygdomme og hypertension

+4578436580

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026