Efficacy and tolerability of nicotinamide as add-on therapy compared to placebo in dialysis-dependent patients with elevated phosphat level

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

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 < 2.8 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

Exclusion Criteria

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 3 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 month
Patients with dysphagia or swallowing difficulties in the last 6 month
Intestinal obstructions / ileus in the last 6 month
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, maculopathy, severe nonproliferative retinopathy or proliferative retinopathy)
Severe hepatic parenchymal diseases
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 pressure of the last 6 measurement in the last 2 weeks prior screening > 180 mmHg systolic or > 110 mmHg diastolic.
Change of dialysis mode planned in the next year
Pregnant women or positive pregnancy test

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Nicotinamide MR compared to placebo as an add-on therapy to approved individual phosphate binders in the long term reduction of elevated phosphate levels in haemodialysis patients;Secondary Objective: not applicable;Primary end point(s): Serum phosphate concentration;Timepoint(s) of evaluation of this end point: 12 weeks post baseline

Secondary Outcome Measures

Name	Time	Method

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