Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Information source: Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease; Hemodialysis; Hyperphosphatemia
Intervention: Nicotinamide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Medice Arzneimittel Pütter GmbH & Co KG Official(s) and/or principal investigator(s): Walter Zidek, Prof. Dr., Study Director, Affiliation: Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
Summary
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum
phosphate levels of dialysis patients in a dose dependent manner.
Clinical Details
Official title: Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: serum phosphate
Secondary outcome: serum phosphateserum calcium serum PTH adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Alsfeld 36304, Germany
Arnstadt 99310, Germany
Augsburg 86157, Germany
Berlin Hellersdorf 12627, Germany
Berlin Kreuzberg 10245, Germany
Berlin 12045, Germany
Berlin 12203, Germany
Berlin 12435, Germany
Berlin 13051, Germany
Bielefeld 33602, Germany
Coburg 96450, Germany
Darmstadt 64295, Germany
Dortmund 44135, Germany
Dülmen 48249, Germany
Düsseldorf 40210, Germany
Elsenfeld 63820, Germany
Erfurt 99089, Germany
Essen 45127, Germany
Friedrichsroda 99894, Germany
Hamburg 22297, Germany
Hameln 31787, Germany
Herne 44623, Germany
Herzberg 04916, Germany
Iserlohn 58638, Germany
Jena-Drakendorf 07751, Germany
Kamen 59174, Germany
Leverkusen 51373, Germany
Mannheim 68309, Germany
Minden 32429, Germany
Nordhausen 99734, Germany
Osnabrueck 49074, Germany
Pfarrkirchen 84347, Germany
Regensburg 93053, Germany
Schwabach 91126, Germany
Tangermünde 39590, Germany
Wuppertal 42283, Germany
Additional Information
Starting date: August 2010
Last updated: January 16, 2012
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