EUCTR2013-000488-95-PL进行中（未招募）1 期
Efficacy and tolerability of nicotinamide as add-on therapy compared to placebo in dialysis-dependent patients with hyperphosphatemia - NOPHOS Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males or females aged 18 years or older
- •Patients with CKD stage 5 and on a stable haemodialysis regimen, 3 times a week for at least 6 months prior to screening
- •Dialysis sessions must be conducted either on Sunday, Monday (morning, midday/afternoon, evening or overnight) or on Tuesday (morning or midday/afternoon)
- •Dialysis regime must remain constant at least until visit W12
- •Unmodified phosphate binding therapy with one or two phosphate binders for at least 1 month prior to screening
- •Serum phosphate concentration at screening < 2.80 mmol/l (8,7 mg/dl) and > 1.45 mmol/l (4.5 mg/dl)
- •If the patient is on vitamin D replacement and/or active vitamin D therapy, the dose must have remained stable for at least 1 month prior to screening
- •If the patient takes calcimimetics, the dose must have remained stable for at least 1 month prior to screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 385
排除标准
- •Chronic heart failure NYHA III or IV in adequate volume state.
- •Cardiac decompensation, which required hospital admission in the last 6 months
- •Myocardial infarction in the last 6 months
- •Uncontrolled hypertension although receiving 3 or more antihypertensive medications
- •Patient with planned parathyroidectomy in the next year
- •High urgency transplant candidate as defined at Eurotransplant at screening
- •Peptic ulcers in the last 6 months
- •Gastro-intestinal hemorrhage - except anal skin tags - in the last 6 months
- •Patients with dysphagia or swallowing difficulties - in the last 6 months
- •Intestinal obstructions / ileus - in the last 6 months
- •Patients with impaired intestinal absorption (e.g. impaired intestinal motility, pseudo-obstructions, megacolon, short bowel syndrome, Crohn's or coeliac disease)
- •Active gastroparesis, identifiable from nausea and vomiting
- •Rhabdomyolysis
- •Severely impaired vision (e.g. macular edema, severe nonproliferative retinopathy or proliferative retinopathy)
- •Severe liver disease (especially persistent Hepatitis B/C/D with viral load, cirrhosis or severe fibrosis according to IASL (numerous bridges or septa, liver cancer, liver transplantation planned or performed)
- •Hypersensitivity to nicotinamide or one of the other ingredients
- •Absolute or severe lactose intolerance
- •Simultaneous participation in another clinical trial within the last 2 months
- •Patients who are legally incapacitated or are institutionalized by court or official order
- •Patient with an inadequate command, or no command of written and spoken national language
- •Failure to use highly-effective contraceptive methods in women of child-bearing age
- •Poorly controlled diabetes (HbA1c > 9%) at screening
- •Platelet count < 120/nl at screening
- •BMI < 19 at screening
- •Calcium > 2.65 mmol/l (10.6 mg/dl) at screening
- •Pathological creatine kinase value may not be = 2 times the normal range (men > 380 U/l, women > 334 U/l) at screening;
- •Elevated transaminases (AST or ALT) more than 3 times the normal level at screening
- •Haemoglobin level < 8 g/dl at screening
- •Mean blood presure of the last 6 measurement in the last 2 weeks prior screening > 160 mmHg systolic or > 100 mmHg diastolic
- •Change of dialysis mode planned in the next year
- •Pregnant women or positive pregnancy test
研究者
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