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PRAISE: Prednisolone Treatment in Acute Interstitial Nephritis

Sponsor
Region MidtJylland Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04376216
Collaborator
Aarhus University Hospital (Other), Odense University Hospital (Other)
110
Enrollment
1
Location
2
Arms
120
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
Actual Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. eGFR [3 months]

      Kidney function

    Secondary Outcome Measures

    1. eGFR [12 months]

      Kidney function

    2. 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

    3. 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

    4. Need for renal replacement therapy [3 and 12 months]

      Dialysis need

    5. Plasma glucose or hemoglobin A1C [3 and 12 months]

      Development of diabetes (safety)

    6. 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

    7. Infections (number of events) [3 and 12 months]

      Safety

    8. Admissions (number of events) [3 and 12 months]

      Safety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Godstrup Hospital Herning Denmark 7400

    Sponsors and Collaborators

    • Region MidtJylland Denmark
    • Aarhus University Hospital
    • Odense University Hospital

    Investigators

    • Study Chair: Jesper N Bech, MD, Region MidtJylland Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frank Mose, Associate professor, Region MidtJylland Denmark
    ClinicalTrials.gov Identifier:
    NCT04376216
    Other Study ID Numbers:
    • FHM-1-2017
    First Posted:
    May 6, 2020
    Last Update Posted:
    Dec 30, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Frank Mose, Associate professor, Region MidtJylland Denmark
    Acute Tubulo-Interstitial Nephritis
    Prednisone
    Additional relevant MeSH terms:
    Nephritis
    Nephritis, Interstitial
    Prednisone
    Prednisolone

    Study Results

    No Results Posted as of Dec 30, 2020