Prednisolone Treatment in Acute Interstitial Nephritis

Study Overview
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Brief Summary
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A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis

Official Title
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Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie

Conditions
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Acute Tubulo-Interstitial Nephritis

Intervention / Treatment
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* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No treatment | |
| Active Comparator: Prednisone<br>Oral prednisone. Starting dose of 60 mg with tapering for 2 months | Drug: Prednisone<br>* 60 mg with dose tapering over 2 months<br>* Other names: Prednisolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR | Kidney function | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR | Kidney function | 12 months | 
| Urinary biomarkers | NGAL, NAG, KIM-1, TIMP-2, IGFBP7, IL-6, IL-18 and MCP-1 are the biomarkers that the investigators plan to analyze | at inclusion and after3 and 12 months | 
| Pathology | 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 | At inclusion | 
| Need for renal replacement therapy | Dialysis need | 3 and 12 months | 
| Plasma glucose or hemoglobin A1C | Development of diabetes (safety) | 3 and 12 months | 
| Treatment delay | 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 | At inclusion | 
| Infections (number of events) | Safety | 3 and 12 months | 
| Admissions (number of events) | Safety | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Tubulo-Interstitial Nephritis, Prednisone