Prednisolone Treatment in Acute Interstitial Nephritis | NCT04376216

Studies
Prednisolone Treatment in Acute Interstitial Nephritis

NCT04376216

Sponsor

Region MidtJylland Denmark

Status

Recruiting

Last Update Posted

Dec 30, 2020Actual

Enrollment

110Estimated

Phase

Phase 4

Conditions

Acute Tubulo-Interstitial Nephritis

Interventions

Prednisone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2027Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

May 5, 2020

First Posted Date

May 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2020

Last Update Posted Date

Dec 30, 2020Actual

Name	Class
Aarhus University Hospital	OTHER
Odense University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	No treatment
Prednisone	Active Comparator	Oral prednisone. Starting dose of 60 mg with tapering for 2 months	Drug: Prednisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisone	Drug	60 mg with dose tapering over 2 months	Prednisone	Prednisolone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
eGFR	Kidney function	3 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Frank Mose, MD	Contact	+4528531257		frchri@rm.dk

Name	Affiliation	Role
Jesper N Bech, MD	Region MidtJylland Denmark	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Godstrup Hospital	Recruiting	Herning		7400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33933012	Derived	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.

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473