Prednisolone Treatment in Acute Interstitial Nephritis

Phase 4

Recruiting

• Conditions: Acute Tubulo-Interstitial Nephritis
• Interventions: Drug: Prednisone

• Registration Number: NCT04376216
• Lead Sponsor: Region MidtJylland Denmark

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-06
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-30
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone	Prednisone	Oral prednisone. Starting dose of 60 mg with tapering for 2 months

Primary Outcome Measures

Name	Time	Method
eGFR	3 months	Kidney function

Secondary Outcome Measures

Name	Time	Method
eGFR	12 months	Kidney function
Need for renal replacement therapy	3 and 12 months	Dialysis need
Urinary biomarkers	at inclusion and after3 and 12 months	NGAL, NAG, KIM-1, TIMP-2, IGFBP7, IL-6, IL-18 and MCP-1 are the biomarkers that the investigators plan to analyze
Plasma glucose or hemoglobin A1C	3 and 12 months	Development of diabetes (safety)
Treatment delay	At inclusion	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
Infections (number of events)	3 and 12 months	Safety
Pathology	At inclusion	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
Admissions (number of events)	3 and 12 months	Safety

Trial Locations

Locations (1)

Godstrup Hospital; 🇩🇰 Herning, Denmark