Dapagliflozin and Hydrochlorothiazide Treatment in Recurring Kidney Stone Patients - a Randomised Single Center Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Δ of urinary oxalate excretion
研究概览
简要总结
Current prevention strategies in patients with recurrence of kidney stones show especially in high-risk patients a diversely and in the long-term not successful outcome in a sustainable number of cases. Recent studies have revealed that Dapagliflozin has the potential to decrease risk and incidence of urolithiasis events especially in patients suffering from Diabetes. The investigators propose that Dapagliflozin has the potential to increase the metabolic situation of hyperoxaluric patients with recurrence of urolithiasis. The investigators therefore test whether Dapagliflozin can decrease the oxalate excretion compared to the current strategy with Hydrochlorothiazide. The study may open up a new way of preventing urolithiasis in patients with high-risk of recurring urolithiasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Calcium-oxalate stone formers with high risk of reoccurrence defined as:
- •At least two symptomatic or surgically treated kidney stones within the last 10 years and/or
- •Single stone kidney formers with risk factors including: a.) Positive medical family history on kidney stone formations of at least one blood related relative in the first degree or at least two blood related relatives in the second degree and/ or b.) Onset of kidney stone formations within the third life decade or earlier and/ or c.) Metabolic syndrome d.) Obesity (BMI ≥ 30 kg/m²)
排除标准
- •Age < 18 years
- •Malabsorption disorder
- •eGFR < 30 ml/min/1,73 m2
研究组 & 干预措施
Washout Phase and treatment arms
At first there will be wash-out phase I with daily placebo administration for all participants. All patients will receive blood- and 24h-urine screenings in week 0 and 6 to get baseline data and also a low-dose native CT of the urinary tract in week 6. In preparation of the HCT phase all participants will daily receive an oral placebo.
In week 7 the HCT phase will start and all patients will receive an oral therapy with 50mg of HCT daily; the treatment response will be evaluated by blood- and urine test after 4 weeks of therapy (week 10).
After that, in washout phase II, the same test as before will be performed in week 0 and 6 (weeks 15 and 20).
At the end another therapy phase with an oral administration of 10mg dapagliflozin daily will be performed; the treatment response will be evaluated by blood- and urine test after 4 weeks of therapy (week 25).
Finally, the same tests as before will be performed in wash-out phase III in week 0 and 6 (weeks 29 and 34).
干预措施: Dapagliflozin (Drug)
Washout Phase and treatment arms
At first there will be wash-out phase I with daily placebo administration for all participants. All patients will receive blood- and 24h-urine screenings in week 0 and 6 to get baseline data and also a low-dose native CT of the urinary tract in week 6. In preparation of the HCT phase all participants will daily receive an oral placebo.
In week 7 the HCT phase will start and all patients will receive an oral therapy with 50mg of HCT daily; the treatment response will be evaluated by blood- and urine test after 4 weeks of therapy (week 10).
After that, in washout phase II, the same test as before will be performed in week 0 and 6 (weeks 15 and 20).
At the end another therapy phase with an oral administration of 10mg dapagliflozin daily will be performed; the treatment response will be evaluated by blood- and urine test after 4 weeks of therapy (week 25).
Finally, the same tests as before will be performed in wash-out phase III in week 0 and 6 (weeks 29 and 34).
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Δ of urinary oxalate excretion
时间窗: 8 weeks
As the primary endpoint the investigators defined the change of the urine oxalate excretion assessed by 24 h hour urine by 25% after 8 weeks of SGLT-2 inhibitor therapy compared to the baseline value that was collected in the washout phase before the treatment period. (Δ week0 and week 8 in mmol/L)
次要结局
- Δ of urinary calcium excretion(8 weeks)
- Change of eGFR(8 weeks)
- Change of serum kreatinine(8 weeks)
- Frequency of urolithiasis(12 months)
- Tolerability of SGLT-2inhibitor therapy(8 weeks)
研究者
Zeljko Kikic
Assoc.Prof.Priv.Doz.Dr.
Medical University of Vienna