Back to resultsPrednisolone Treatment in Acute Interstitial Nephritis (PRAISE)
Primary Purpose
Acute Tubulo-Interstitial Nephritis
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Acute Tubulo-Interstitial Nephritis focused on measuring Acute Tubulo-Interstitial Nephritis, Prednisone
Eligibility Criteria
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
Sites / Locations
- Godstrup HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Prednisone
Arm Description
No treatment
Oral prednisone. Starting dose of 60 mg with tapering for 2 months
Outcomes
Primary Outcome Measures
eGFR
Kidney function
Secondary Outcome Measures
eGFR
Kidney function
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
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
Need for renal replacement therapy
Dialysis need
Plasma glucose or hemoglobin A1C
Development of diabetes (safety)
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
Infections (number of events)
Safety
Admissions (number of events)
Safety
Full Information
NCT ID
NCT04376216
First Posted
April 27, 2020
Last Updated
December 29, 2020
Sponsor
Region MidtJylland Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04376216
Brief Title
Prednisolone Treatment in Acute Interstitial Nephritis
Acronym
PRAISE
Official Title
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region MidtJylland Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Tubulo-Interstitial Nephritis
Keywords
Acute Tubulo-Interstitial Nephritis, Prednisone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment
Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Oral prednisone. Starting dose of 60 mg with tapering for 2 months
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Prednisolone
Intervention Description
60 mg with dose tapering over 2 months
Primary Outcome Measure Information:
Title
eGFR
Description
Kidney function
Time Frame
3 months
Secondary Outcome Measure Information:
Title
eGFR
Description
Kidney function
Time Frame
12 months
Title
Urinary biomarkers
Description
NGAL, NAG, KIM-1, TIMP-2, IGFBP7, IL-6, IL-18 and MCP-1 are the biomarkers that the investigators plan to analyze
Time Frame
at inclusion and after3 and 12 months
Title
Pathology
Description
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
Time Frame
At inclusion
Title
Need for renal replacement therapy
Description
Dialysis need
Time Frame
3 and 12 months
Title
Plasma glucose or hemoglobin A1C
Description
Development of diabetes (safety)
Time Frame
3 and 12 months
Title
Treatment delay
Description
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
Time Frame
At inclusion
Title
Infections (number of events)
Description
Safety
Time Frame
3 and 12 months
Title
Admissions (number of events)
Description
Safety
Time Frame
3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Mose, MD
Phone
+4528531257
Email
frchri@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper N Bech, MD
Organizational Affiliation
Region MidtJylland Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Godstrup Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Mose
Phone
28531257
Email
frchri@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will be decided
Citations:
PubMed Identifier
33933012
Citation
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.
Results Reference
derived
Learn more about this trial
Prednisolone Treatment in Acute Interstitial Nephritis
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