Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
NCT ID: NCT01200784
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
252 participants
INTERVENTIONAL
2010-08-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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250 mg/d modified release Nicotinamide
Nicotinamide
dosage
500 mg/d modified release Nicotinamide
Nicotinamide
dosage
750 mg/d modified release Nicotinamide
Nicotinamide
dosage
1000 mg/d modified release Nicotinamide
Nicotinamide
dosage
1000 mg/d immidiate release Nicotinamide
Nicotinamide
dosage
Interventions
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Nicotinamide
dosage
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medice Arzneimittel Pütter GmbH & Co KG
INDUSTRY
Responsible Party
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Principal Investigators
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Walter Zidek, Prof. Dr.
Role: STUDY_DIRECTOR
Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
Locations
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Alsfeld, , Germany
Arnstadt, , Germany
Augsburg, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Bielefeld, , Germany
Coburg, , Germany
Darmstadt, , Germany
Dortmund, , Germany
Dülmen, , Germany
Düsseldorf, , Germany
Elsenfeld, , Germany
Erfurt, , Germany
Essen, , Germany
Friedrichsroda, , Germany
Hamburg, , Germany
Hamelin, , Germany
Hellersdorf, , Germany
Herne, , Germany
Herzberg, , Germany
Iserlohn, , Germany
Jena-Drakendorf, , Germany
Kamen, , Germany
Kreuzberg, , Germany
Leverkusen, , Germany
Mannheim, , Germany
Minden, , Germany
Nordhausen, , Germany
Osnabrück, , Germany
Pfarrkirchen, , Germany
Regensburg, , Germany
Schwabach, , Germany
Tangermünde, , Germany
Wuppertal, , Germany
Countries
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Other Identifiers
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2009-015821-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6520-9961-03
Identifier Type: -
Identifier Source: org_study_id
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