NCT03074357已完成不适用
Urine, DNA and Retrospective Clinical Information Collection From Patients With Alport Nephropathy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Urine levels of biomarkers - corrected for urine creatinine
研究概览
简要总结
This biomarker study is a follow-up to CPLATFRM2201. The goal of CBASICHR0005 is to collect another urine sample, interval clinical information, and an optional DNA sample from as many of the original 80 patients as possible. This new information will transform the data obtained in PLATFRM2201 from a cross-section to a temporal profile, which will (a) further enable the identification of biomarkers predictive of faster progression, and (b) satisfy the FDA's recommendation to perform "natural history studies" in rare diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study and able to provide written informed consent (parent or legal guardian for pediatric and adolescent subjects), which must be obtained before any assessment is performed.
- •Alport Subject-Specific Inclusion Criteria:
- •Participation in CPLATFRM2201
- •Physically able to provide a single first-morning urine sample of at least 30 mL (one ounce). Alport patients who have initiated dialysis therapy since participation in CPLATFRM2201 are exempt from this criterion and may still participate in this study.
- •Healthy Volunteer-Specific Inclusion Criteria:
- •Male and Female Volunteers (may include healthy siblings of Alport patients) aged 5 to 15 years.
排除标准
- •Alport Subject-Specific Exclusion Criteria:
- •Healthy Volunteer-Specific Exclusion Criteria:
- •Use of investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •Known history of one of more of (a) hematuria (gross or microscopic), (b)audiological deficits, (c) fixed (non-orthostatic) proteinuria, or (d) reduced renal filtration function with serum creatinine (Cr) above the upper limit of the normal age-specific reference range, on at least 2 prior occasions (serum Cr need not be measured specifically for eligibility).
- •Any other clinically significant underlying medical conditions as judged by the PI.
结局指标
主要结局
Urine levels of biomarkers - corrected for urine creatinine
时间窗: Day 1
Urine levels of biomarkers, corrected for urine creatinine, in Alport subjects stratified by magnitude of proteinura.
次要结局
- Urine level of biomarkers - corrected for urine creatinine(Day 1)
研究者
研究点 (1)
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