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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


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 phosphate

serum calcium

serum PTH

adverse events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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