Prednisolone Treatment in Acute Interstitial Nephritis (PRAISE)

Region MidtJylland Denmark

Status and phase: Enrolling; Phase 4

Conditions: Acute Tubulo-Interstitial Nephritis

Treatments: Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT04376216

FHM-1-2017

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Control

No Intervention group

Description:

No treatment

Prednisone

Active Comparator group

Description:

Oral prednisone. Starting dose of 60 mg with tapering for 2 months

Treatment:

Drug: Prednisone