EUCTR2013-000488-95-AT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
- •? Study visits must be conducted either on Sunday, Monday (morning, midday/afternoon,
- •evening or overnight dialysis session) or on Tuesday (morning or midday/afternoon
- •dialysis sessions)
- •? Dialysis regimen should remain constant at least until study 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 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
- •? Patient is willing and able to regularly attend the examination and follow-up appointments
- •? Written informed consent
- •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 requiring 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 haemorrhage –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 4 (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
- •? Failure to use highly-effective contraceptive methods in women of child-bearing age. The
- •following contraceptive methods with a Pearl Index lower than 1% are regarded as
- •highly-effective:
- •? Tubal ligation (female sterilisation)
- •? Intrauterine devices that release hormones (hormone spiral)
- •? Vaginal hormonal contraception
- •? Dermal hormonal contraception
- •? Contraceptive plaster
- •? Long-acting injectable contraceptives
- •? Implants that release progesterone
- •? Double barrier methods
- •o This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
- •? sexual abstinence or vasectomised partner can also considered as adequate as investigators discretion (taking patient’s medical history and lifestyle into account)
- •? Alcohol, drug or pharmaceutical abuse within the last year prior to trial commencement
- •? Known persistent (> 1 month before inclusion) non compliance (< 70%) with prescribed
- •medication regimes.
- •? Nursing mother
研究者
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