DRKS00003624招募中3 期
Early Prospective Therapy Trial to Delay Renal Failure in Children with Alport Syndrome - EARLY PRO-TECT Alport
niversitätsmedizin Göttingen0 个研究点目标入组 120 人开始时间: 2012年3月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 24 Months 至 17 Years（—）
- 性别
- All
入选标准
- •Definitive diagnosis of Alport syndrome: Kidney biopsy (patient or affected relative/s), and/or mutation analysis (hemizygous X-chromosomal or homozygous autosomal-recessive) and assessment of criteria for clinical diagnosis (haematuria, positive family history regarding kidney diseases, ocular changes, labyrinthine hearing loss)
- •- Alport syndrome levels 0 or I at screening (microhaematuria without microalbuminuria or microalbuminuria [30-300 mg albumin/gCrea]).
- •- Aged between =24 months and <18 years at screening
- •- Assent from patient and informed consent from parents/legal guardian
排除标准
- •- Uncertain diagnosis or variants of Alport syndrome such as a heterozygous carrier
- •- Alport syndrome levels II, , III, or IV (albuminuria >300 mg/g Crea, creatinine clearance <60 mL/min, or end stage renal failure [ESRF])
- •- Known allergies or intolerances to ramipril or related compounds
- •- Known contraindication for ACEi-therapy
- •- Additional chronic renal, pulmonary or cardiac diseases
- •- Pregnancy and lactation
研究者
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