Acute Tubulo-Interstitial Nephritis
Conditions
Keywords
Acute Tubulo-Interstitial Nephritis, Prednisone
Brief summary
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
Interventions
DRUGPrednisone
60 mg with dose tapering over 2 months
Sponsors
Aarhus University Hospital
Odense University Hospital
Region MidtJylland Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR | 3 months | Kidney function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| eGFR | 12 months | Kidney function |
| Urinary biomarkers | at inclusion and after3 and 12 months | NGAL, NAG, KIM-1, TIMP-2, IGFBP7, IL-6, IL-18 and MCP-1 are the biomarkers that the investigators plan to analyze |
| Pathology | At inclusion | Re-evaluation of renal biospies performed at time of inclusion. This evaluation includes the use of routine and special staining for inflammation, fibrosis and tubular damage. The analysis includes an estimation of predictive value of histological scoring on treatment response and prognosis |
| Plasma glucose or hemoglobin A1C | 3 and 12 months | Development of diabetes (safety) |
| Treatment delay | At inclusion | In the prednisolone group the importance of treatment delay is analyzed. Treatment delay is defined as follows: * Days form first symptoms to inclusion in this project * Days from first contact to the Danish health care system to inclusion in this project * Days from first contact to a nephrology department to inclusion in this project |
| Infections (number of events) | 3 and 12 months | Safety |
| Admissions (number of events) | 3 and 12 months | Safety |
| Need for renal replacement therapy | 3 and 12 months | Dialysis need |
Countries
Denmark
Contacts
Primary ContactFrank Mose, MD
Outcome results
None listed