NCT02016235已完成1 期
Role Of Phosphorus And FGF 23 In Patients With Dent Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Urine Total Protein
研究概览
简要总结
Patients with Dent disease have suppressed levels of FGF 23 which contributes to hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with phosphorus may reduce hypercalciuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients will be recruited from those in the RKSC Dent Registry
- •Diagnostic criteria for Dent disease Observational arm include:
- •<18 years old
- •LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria:
- •Hypercalciuria,
- •Kidney stones,
- •Nephrocalcinosis,
- •Hypophosphatemia,
- •Renal phosphate leak,
- •Aminoaciduria,
- •Glucosuria without diabetes mellitus,
- •Renal insufficiency,
- •Family history with x-linked inheritance or
- •1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL
- •Diagnostic criteria for Dent disease Intervention arm include:
- •>18 years old
- •LMWP (at least 5 times above the upper limit of normal) and at least 1 of the following criteria:
- •Hypercalciuria,
- •Kidney stones,
- •Nephrocalcinosis,
- •Hypophosphatemia,
- •Renal phosphate leak,
- •Aminoaciduria,
- •Glucosuria without diabetes mellitus,
- •Renal insufficiency,
- •Family history with x-linked inheritance or
- •1 of the above criteria (1-9) and confirmed genetic mutation of CLCN5 or OCRL
- •Idiopathic calcium nephrolithiasis with renal phosphate leak
- •Male patients > 18 years old
- •History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (>250 mg/24 hrs), renal phosphate leak (TMP/GFR <2.07 mg/dl)
- •Idiopathic calcium nephrolithiasis without renal phosphate leak
- •Male patients > 18 years old
- •History of symptomatic calcium oxalate or calcium phosphate stone, hypercalciuria (>250 mg/24 hrs), renal phosphate leak (TMP/GFR <2.07 mg/dl)
排除标准
- •Exclusion for Dent disease include: primary or secondary hyperparathyroidism, hyperthyroidism, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
- •Exclusion criteria for calcium stone formers include: primary or secondary hyperparathyroidism, hyperthyroidism, estimated GFR <40 ml/mn/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
- •Exclusion criteria include history of symptomatic or asymptomatic kidney stone disease; primary or secondary hyperparathyroidism; estimated GFR <40 ml/min/1.73m2, chronic diarrhea states; intake of thiazide diuretics, glucocorticoids, or estrogens within one month of the study.
研究组 & 干预措施
Dent Disease Intervention
Experimental
Dent Disease subjects will receive 2 week supplementation with phosphorus
干预措施: Phosphorus Supplement (Drug)
Kidney Stone subjects
Experimental
Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus
干预措施: Phosphorus Supplement (Drug)
Dent Disease Observation
Placebo Comparator
Dent disease subjects will not get phosphorus
干预措施: Observation (Other)
结局指标
主要结局
Change in Urine Total Protein
时间窗: baseline, day 7
Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)Kidney DiseaseNCT00843349Myles Wolf43
已完成
4 期
Effect of Phosphate Binders on FGF-23 With Concurrent CalcitriolChronic Kidney Disease Stage 3NCT01748396Seoul National University Hospital30
已完成
早期 1 期
Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney DiseaseChronic Kidney DiseaseNCT01308242Milton S. Hershey Medical Center40
已完成
不适用
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney DiseaseSecondary HyperparathyroidismNCT00999037University of California, Los Angeles18
已完成
不适用
Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.MalnutritionNCT02812134Centre Hospitalier Universitaire, Amiens30