Prednisolone Treatment in Acute Interstitial Nephritis

Acute Tubulo-Interstitial Nephritis Clinical Trial

— PRAISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376216
• Other study ID #: FHM-1-2017
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acute Tubulo-Interstitial Nephritis
• Nephritis
• Nephritis, Interstitial

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