Early prospective therapy trial to delay renal failure in children with Alport syndrome. - EARLY PRO-TECT Alport

niversity Medical Center Göttingen0 个研究点目标入组 66 人开始时间: 2011年12月12日最近更新: 2021年3月8日

适应症

试验速览

暂无简介。

•- 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, I or II at screening (microhaematuria without microalbuminuria or microalbuminuria [30-300 mg albumin/gCrea]) or proteinuria >300 mg albumin/gCrea with GFR>80ml/min). Patients with Alport stage II are not subject to randomization but are treated opel label.
•- Aged between =24 months and <18 years at screening
•- Assent from patient and informed consent from parents/legal guardian
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 120
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Uncertain diagnosis or variants of Alport syndrome such as a heterozygous carrier
•- Alport syndrome levels III, or IV (creatinine clearance <80 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

发起方

niversity Medical Center Göttingen