Prednisolone Treatment in Acute Interstitial Nephritis (PRAISE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Tubulo-Interstitial Nephritis
• Intervention / Treatment: Drug: Prednisone

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Frank Mose, MD; Phone Number: +4528531257; Email: frchri@rm.dk

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Recruiting
    • Godstrup Hospital
    • Contact: Frank Mose; Phone Number: 28531257; Email: frchri@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No treatment
Active Comparator: Prednisone; Oral prednisone. Starting dose of 60 mg with tapering for 2 months	Drug: Prednisone; 60 mg with dose tapering over 2 months; Other Names: Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR	Kidney function	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region MidtJylland Denmark
• Collaborators: Odense University Hospital; Aarhus University Hospital
• Investigators: Study Chair: Jesper N Bech, MD, Region MidtJylland Denmark

Publications and helpful links

General Publications

• Mose FH, Birn H, Hoffmann-Petersen N, Bech JN. Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial. BMC Nephrol. 2021 May 1;22(1):161. doi: 10.1186/s12882-021-02372-4.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Prednisone; Acute Tubulo-Interstitial Nephritis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Nephritis; Nephritis, Interstitial; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone; Prednisone
• Other Study ID Numbers: FHM-1-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Will be decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No