Prednisolone treatment in acute interstitial nephritis
- Conditions
- Acute interstitial nephritisMedDRA version: 21.1Level: PTClassification code 10048302Term: Tubulointerstitial nephritisSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 21.1Level: LLTClassification code 10000819Term: Acute interstitial nephritisSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 21.1Level: LLTClassification code 10022614Term: Interstitial nephritis acuteSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-000992-10-DK
- Lead Sponsor
- niversitets klinik for nyresygdomme og Hypertension
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 110
•Biopsi proven acute interstitial nephritis (AIN).
•Clinical suspision of AIN
•Age of minimum 18 years.
•one of the two following criteria
oCreatinine > 120 m?mol/l or
oCreatinine 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
•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
- Secondary Outcome Measures
Name Time Method