Prednisolone Treatment in Acute Interstitial Nephritis

Launched by REGION MIDTJYLLAND DENMARK · May 5, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called prednisolone on patients with a condition known as Acute Interstitial Nephritis (AIN), which is a type of kidney inflammation. The main goal is to see how well this treatment works for patients diagnosed with AIN, and the trial is currently looking for participants aged 18 and older. To be eligible, participants must have a confirmed diagnosis of AIN through a kidney biopsy, and their kidney function must show specific signs of impairment, such as elevated blood creatinine levels.

If you or a loved one qualify and decide to participate, you will be randomly assigned to receive either prednisolone or a different treatment. The study is open to both men and women, including those who are fertile. However, certain conditions may prevent participation, such as recent use of immunosuppressive medications, pregnancy, or having certain serious health issues. Participants will be closely monitored throughout the trial to ensure their safety and to evaluate how well the treatment is working. This study aims to provide better treatment options for those affected by AIN.

Gender

ALL

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