Nicotinamide in Hemodialysis Patients With Hyperphosphatemia (DONATO)

Medice Arzneimittel

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Hemodialysis; Hyperphosphatemia

Treatments: Drug: Nicotinamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01200784

6520-9961-03

2009-015821-34 (EudraCT Number)

Details and patient eligibility

About

Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hemodialysis since 3 months or longer
• hemodialysis frequency 3 times weekly
• stable phosphate binder dose since one month at screening
• serum phosphate level < 2,42 mmol/l at screening
• serum phosphate level > 1,52 mmol/l after wash out phase
• stable treatment with vitamin D analogues since one month at screening

Exclusion criteria

• congestive heart failure
• acute bleeding complications
• acute myocardial infarction
• peptic ulcers
• serious liver damage
• poorly controlled diabetes
• severe visual impairment
• uncontrolled high blood pressure
• thrombocyte count < 120/nl
• difficulties in swallowing or dysphagia
• diminished intestinal motility, megacolon, pseudo- or mechanical obstruction
• gastroparesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 5 patient groups

250 mg/d modified release Nicotinamide

Experimental group

Treatment:

Drug: Nicotinamide

500 mg/d modified release Nicotinamide

Experimental group

Treatment:

Drug: Nicotinamide

750 mg/d modified release Nicotinamide

Experimental group

Treatment:

Drug: Nicotinamide

1000 mg/d modified release Nicotinamide

Experimental group

Treatment:

Drug: Nicotinamide

1000 mg/d immidiate release Nicotinamide

Active Comparator group

Treatment:

Drug: Nicotinamide