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NCT Number: NCT04376216

Prednisolone Treatment in Acute Interstitial Nephritis

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

Recruiting

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Key information

Conditions

Acute Tubulo-Interstitial Nephritis Acute Tubulointerstitial Nephritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Godstrup Hospital

Herning, 7400, Denmark

Location status: Recruiting

Location contact

Frank Mose

CONTACT

[email protected]

28531257

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

60 mg with dose tapering over 2 months

Other names: Prednisolone

Primary outcomes

  1. eGFR

    Time frame: 3 months

    Kidney function

Secondary outcomes

  1. eGFR

    Time frame: 12 months

    Kidney function

  2. Urinary biomarkers

    Time frame: 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

    Time frame: 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

    Time frame: 3 and 12 months

    Dialysis need

  5. Plasma glucose or hemoglobin A1C

    Time frame: 3 and 12 months

    Development of diabetes (safety)

  6. Treatment delay

    Time frame: 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)

    Time frame: 3 and 12 months

    Safety

  8. Admissions (number of events)

    Time frame: 3 and 12 months

    Safety

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Mose, MD

CONTACT

[email protected]

+4528531257

Sponsors and collaborators

Lead sponsor

Region MidtJylland Denmark

Other

Collaborators

  • Aarhus University Hospital
  • Odense University Hospital

Registry information

Official study title

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

Acronym: PRAISE

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
May 6, 2020
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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