2024-520299-86-00招募中4 期
Prednisone treatment in acute interstitial nephritis - a randomized prospective trial (PRAISE)
Region Midtjylland9 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年1月13日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 9
- 主要终点
- eGFR at 3 months
研究概览
简要总结
To investigate the effect of prednisolone treatment in acute interstitial nephritis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Biopsi proven acute interstitial nephritis (AIN), Clinical suspision of AIN, Age of minimum 18 years, One of the two following criteria: Creatinine > 120 mmol/l or Creatinine increase of > 30 mmol/l or 1,5 x creatinine-increase, Women with child bearing potential
排除标准
- •Not able to give consent. • IImmunosuppressive therapy within 3 months • Autoimmune disease. • Allergy or intolerance towards MP eller prednisolone. • Pregnancy or nursing • Active cancer except basal celle carcinoma. • Terminal illness with life expectancy of less than 6 months • CKD 4 or 5 • Previous participation • AIN associated with glomerulonefritis, sarcoidosis eller inherited interstitial kidney diseases
结局指标
主要结局
eGFR at 3 months
eGFR at 3 months
次要结局
- Kidney function (eGFR) at 12 months, CKD stage, Number og patients in dialysis, Effekt of treatment-delay on outcome, Urinary biomarkers, Questionaire: SF36 score, The predictive value of histopathological evaluation, Safety endpoints: P-glukose, Infections, Submissions
研究者
Jesper Nørgaard Bech
Scientific
Region Midtjylland
研究点 (9)
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