Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis: a Short-term, Prospective, Open-label, Efficacy and Safety Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg
研究概览
简要总结
This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.
详细描述
Nephrolithiasis/urolithiasis is a prevalent (overall lifetime risk up to 13% in Western countries) and highly recurrent disease. Secondary hyperoxaluria is a key risk factor for the development of calcium oxalate stones, the most frequent stone type. Currently used therapeutic options in secondary hyperoxaluria have limited efficacy. Recent findings in vitro and in a rat model, provided evidence that Lanthanum Carbonate is an effective oxalate binder. The objective of this study is to investigate whether treatment with Lanthanum Carbonate reduces urinary oxalate excretion in human subjects with secondary hyperoxaluria and nephrolithiasis. By treating the patients with two different doses of Lanthanum Carbonate during two 14-day treatment periods, a dose-response will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to give written informed consenct
- •hyperoxaluria (defined as urinary oxalate > 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit
- •history of nephrolithiasis eGFR > 60 mL/min/1.73m² (CKD-EPI formula)
排除标准
- •primary hyperoxaluria, diagnosed by genetic testing
- •known allergy to Lanthanum Carbonate
- •hypophosphatemia (defined as serum phosphorus < 0.81 mmol/L)
- •severe known liver insufficiency of biliary obstruction
- •rectocolitis ulcerohaemorraghica, Crohn's disease, bowel obstruction, stomach/duodenal ulceration
- •glucose/galactose malabsorption
- •severe diarrhea or other gastrointestinal disorder, which might interfere with the ability to absorb oral medication
- •pregnancy or breast-feeding
- •female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study
- •female participant without negative serum or urine pregnancy test
- •psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study
- •currently participating in another clinical trial
研究组 & 干预措施
Experimental single arm
Treatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period.
干预措施: Lanthanum Carbonate (Drug)
结局指标
主要结局
The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg
时间窗: After the first 14-day treatment period
Mean reduction in urinary oxalate excretion after the first 14-day treatment period during which patients will be treated with 250 mg Lanthanum Carbonate 3x/day with meals, expressed in mg oxalate/g creatinine.
次要结局
- The evolution of phosphaturia, evaluated by urinary phosphorus to creatinine ratio(After the first and second 14-day treatment period)
- The incremental reduction in mean urinary oxalate excretion after doubling the dose of Lanthanum Carbonate from 750 mg tot 1500 mg daily(After the second 14-day treatment period)
- The proportion of patients developing severe hypophosphatemia(After the first and second 14-day treatment period)
- The proportion of patients developing hypophosphaturia(After the first and second 14-day treatment period)
- The evolution of calciuria, evaluated by 24-hour urinary calcium excretion(After the first and second 14-day treatment period)
- The evolution of calciuria, evaluated by urinary calcium to creatinine ratio(After the first and second 14-day treatment period)
- The evolution of calciuria, evaluated by fractional excretion of calcium(After the first and second 14-day treatment period)
- The evolution of phosphaturia, evaluated by 24-hour urinary phosphorus excretion(After the first and second 14-day treatment period)
- The evolution of phosphaturia, evaluated by fractional excretion of phosphorus(After the first and second 14-day treatment period)
- The evolution of serum Lanthanum levels(After the first and second 14-day treatment period)
- Adverse events(After the first and second 14-day treatment period)