NCT02830009已完成不适用
IDENTIFICATION OF A MULTI-ANALYTE PROFILE FOR PRIMARY HYPEROXALURIA AND COMPARISON WITH HEALTHY SIBLINGS AND IDIOPATHIC HYPERCALCIURIA
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- presence of protein markers in urine
研究概览
简要总结
The aim of this study is to know the difference between protein profiles (multi-analyte profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings. Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also leads to the formation of kidney stones.
The aim is to identify patterns of discriminating markers associated with primary hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with primary hyperoxaluria, type 1 (PH1-Cohort A); OR
- •Confirmed with AGXT mutation analysis (PH1-Cohort A)
- •Diagnosed with idiopathic hypercalciuria (IHC- Cohort B);
- •Potential subject diagnosed with PH1 or IH and has both data entered into the registry and has matched, archived random and 24-hour urine specimens obtained prior to any treatment intervention OR is consented and enrolled into the registry or this specific study during the program;
- •Healthy siblings of PH1 patients known not to have PH or any another stone disease or chronic disease will be consented and enrolled into this study through the local sites where their sibling is being treated for PH1 (this study meets the criteria for expedited review through local or central IRBs);
- •Healthy non-sibling controls known not to have PH or any another stone disease or chronic disease (Healthy Control-Cohort C);
- •There is no upper or lower limit to the pediatric age range of enrolling infant, children and adolescent subjects, although it is understood that accurate and complete 24-hour urine collection in very young children and infants will be problematic and will be seriously considered in advance of individual patient or healthy controls enrollment;
- •eGFR (Glomerular Filtration Rate) > 60 mL/min x 1.73 m2 with PH1 and IH patient cohorts matched by mean eGFR from their initial study (or registry) enrollment/ data collection.
排除标准
- •Unwilling to provide written parent consent or adolescent assent to enroll into the International Registry or this study;
- •Potential PH1, hypercalciuria, or siblings of PH1 patients with other chronic or acute illness or disease that could potentially confound proteomic results;
- •Healthy intra-familial siblings unwilling to provide a blood sample for serum creatinine;
- •Unwilling to provide urine specimens or permit data abstraction for the registry or this study.
- •Not covered by, or having the right to, Social Security
研究组 & 干预措施
Idiopathic hypercalciuria patients
Other
干预措施: Blood sample (Other)
Healthy volunteers
Other
干预措施: Urines samples (Other)
Healthy volunteers
Other
干预措施: Blood sample (Other)
Primary Hyperoxaluria patient
Other
干预措施: Urines samples (Other)
Primary Hyperoxaluria patient
Other
干预措施: Blood sample (Other)
Primary Hyperoxaluria patient's siblings
Other
干预措施: Urines samples (Other)
Primary Hyperoxaluria patient's siblings
Other
干预措施: Blood sample (Other)
Idiopathic hypercalciuria patients
Other
干预措施: Urines samples (Other)
结局指标
主要结局
presence of protein markers in urine
时间窗: 24 hours
次要结局
- Presence of discriminative and robust protein markers in urine(24 hours)
研究者
研究点 (1)
Loading locations...
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