NCT04376216招募中4 期
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie
Region MidtJylland Denmark1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
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
- 1
- 主要终点
- eGFR
研究概览
简要总结
A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Prednisone
Active Comparator
Oral prednisone. Starting dose of 60 mg with tapering for 2 months
干预措施: Prednisone (Drug)
结局指标
主要结局
eGFR
时间窗: 3 months
Kidney function
次要结局
- Need for renal replacement therapy(3 and 12 months)
- eGFR(12 months)
- Urinary biomarkers(at inclusion and after3 and 12 months)
- Plasma glucose or hemoglobin A1C(3 and 12 months)
- Treatment delay(At inclusion)
- Infections (number of events)(3 and 12 months)
- Pathology(At inclusion)
- Admissions (number of events)(3 and 12 months)
研究者
Frank Mose
Associate professor
Region MidtJylland Denmark
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Prednisone treatment in acute interstitial nephritis (PRAISE)2024-520299-86-00Region Midtjylland110
尚未招募
2 期
Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract SurgeryAge Related CataractPain Management During Cataract SurgeryNCT06614348Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine70
已完成
不适用
A pilot study towards a therapy with prednisolone encapsulated liposomes for the treatment of Graves' Orbitopathy with reduced systemic steroid exposureActive GO (CAS 3 𔂻).NL-OMON24926Het Oogziekenhuis Rotterdam /Rotterdam Ophthalmic Institute<br>PO Box 70030, NL-3000 LM Rotterdam<br>Telephone: +31 (0) 10 4023 44920
Enrolling By Invitation
2 期
Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone AdministrationNCT06223074Universidad Nacional Autonoma de Mexico80
招募中
3 期
PREDICATE Trial For Respiratory Tract InfectionsRespiratory Tract InfectionsNCT06472219The University of Hong Kong1,300