Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Hemodialysis; Hyperphosphatemia
• Interventions: Drug: Nicotinamide

• Registration Number: NCT01200784
• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
250 mg/d modified release Nicotinamide	Nicotinamide	-
750 mg/d modified release Nicotinamide	Nicotinamide	-
500 mg/d modified release Nicotinamide	Nicotinamide	-
1000 mg/d immidiate release Nicotinamide	Nicotinamide	-
1000 mg/d modified release Nicotinamide	Nicotinamide	-

Primary Outcome Measures

Name	Time	Method
serum phosphate	4 weeks of active treatment

Secondary Outcome Measures

Name	Time	Method
serum phosphate	8 weeks of active treatment
serum calcium	4 and 8 weeks of acitve treatment
serum PTH	4 and 8 weeks of active treatment
adverse events	12 weeks