Recruiting NCT04376216
Prednisolone Treatment in Acute Interstitial Nephritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisone.
- Who it may be relevant to
- Registry conditions: Acute Tubulo-Interstitial Nephritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
Overview
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
Interventions
- Drug Prednisone
60 mg with dose tapering over 2 months
Primary outcome measures
- eGFR [Time frame: 3 months]
Secondary outcome measures (8)
- eGFR [Time frame: 12 months]
- Urinary biomarkers [Time frame: at inclusion and after3 and 12 months]
- Pathology [Time frame: At inclusion]
- Need for renal replacement therapy [Time frame: 3 and 12 months]
- Plasma glucose or hemoglobin A1C [Time frame: 3 and 12 months]
- Treatment delay [Time frame: At inclusion]
- Infections (number of events) [Time frame: 3 and 12 months]
- Admissions (number of events) [Time frame: 3 and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Godstrup Hospital — Herning
Publications
- Mose FH, Birn H, Hoffmann-Petersen N, Bech JN. Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial. BMC Nephrol. 2021 May 1;22(1):161. doi: 10.1186/s12882-021-02372-4. PMID 33933012
Identifiers
NCT: NCT04376216 · FHM-1-2017