Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04376216
Other study ID # FHM-1-2017
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2017
Est. completion date September 1, 2027

Study information

Verified date December 2020
Source Region MidtJylland Denmark
Contact Frank Mose, MD
Phone +4528531257
Email frchri@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date September 1, 2027
Est. primary completion date September 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Prednisone
60 mg with dose tapering over 2 months

Locations

Country Name City State
Denmark Godstrup Hospital Herning

Sponsors (3)

Lead Sponsor Collaborator
Region MidtJylland Denmark Aarhus University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary eGFR Kidney function 3 months
Secondary eGFR Kidney function 12 months
Secondary 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
Secondary 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
Secondary Need for renal replacement therapy Dialysis need 3 and 12 months
Secondary Plasma glucose or hemoglobin A1C Development of diabetes (safety) 3 and 12 months
Secondary 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
Secondary Infections (number of events) Safety 3 and 12 months
Secondary Admissions (number of events) Safety 3 and 12 months