Treatment of acute interstitial nephritis with prednisolone
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
PHASE4 · Region MidtJylland Denmark · NCT04376216
This study tests if treating people with acute interstitial nephritis with prednisolone can help improve their kidney function compared to standard care.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region MidtJylland Denmark (other) |
| Locations | 1 site (Herning) |
| Trial ID | NCT04376216 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of prednisolone treatment in patients diagnosed with acute interstitial nephritis (AIN). It is a prospective randomized trial that aims to determine the efficacy of this corticosteroid in improving kidney function in affected individuals. Eligible participants must have biopsy-verified AIN and meet specific criteria related to their plasma creatinine levels. The study will assess the outcomes of treatment compared to standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with biopsy-verified acute interstitial nephritis and elevated plasma creatinine levels.
Not a fit: Patients with autoimmune diseases, recent immunosuppressive treatment, or those with certain kidney conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney function and outcomes for patients with acute interstitial nephritis.
How similar studies have performed: Other studies have explored corticosteroid treatments for kidney conditions, showing varying degrees of success, but this specific approach in AIN is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herning
- Godstrup Hospital — Herning, Denmark (RECRUITING)
Study contacts
- Study coordinator: Frank Mose, MD
- Email: frchri@rm.dk
- Phone: +4528531257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Tubulo-Interstitial Nephritis, Prednisone