Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

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