Prednisolone Treatment in Acute Interstitial Nephritis

Phase 4RecruitingNCT04376216

Region MidtJylland Denmark110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Acute Tubulo-Interstitial Nephritis

Interventions

PrednisoneDRUG

60 mg with dose tapering over 2 months

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Godstrup Hospital

Herning, Denmark

RECRUITING

Outcomes

Primary Outcomes

eGFR

Kidney function

Time frame: 3 months

Secondary Outcomes

eGFR

Kidney function

Time frame: 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

Time frame: 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

Time frame: At inclusion

Need for renal replacement therapy

Dialysis need

Time frame: 3 and 12 months

Plasma glucose or hemoglobin A1C

Development of diabetes (safety)

Time frame: 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

Time frame: At inclusion

Infections (number of events)

Central Contacts

Frank Mose, MD

CONTACT

+4528531257 frchri@rm.dk

Data from ClinicalTrials.gov

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