Clinical trial NCT01200784: Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Official title: Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Hemodialysis
Hyperphosphatemia
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2010-09-14
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: serum phosphate
timeFrame: 4 weeks of active treatment
Secondary outcomes:
measure: serum phosphate
timeFrame: 8 weeks of active treatment
measure: serum calcium
timeFrame: 4 and 8 weeks of acitve treatment
measure: serum PTH
timeFrame: 4 and 8 weeks of active treatment
measure: adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Alsfeld
country: Germany
city: Arnstadt
country: Germany
city: Augsburg
country: Germany
city: Berlin Hellersdorf
country: Germany
city: Berlin Kreuzberg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Coburg
country: Germany
city: Darmstadt
country: Germany
city: Dortmund
country: Germany
city: Dülmen
country: Germany
city: Düsseldorf
country: Germany
city: Elsenfeld
country: Germany
city: Erfurt
country: Germany
city: Essen
country: Germany
city: Friedrichsroda
country: Germany
city: Hamburg
country: Germany
city: Hameln
country: Germany
city: Herne
country: Germany
city: Herzberg
country: Germany
city: Iserlohn
country: Germany
city: Jena-Drakendorf
country: Germany
city: Kamen
country: Germany
city: Leverkusen
country: Germany
city: Mannheim
country: Germany
city: Minden
country: Germany
city: Nordhausen
country: Germany
city: Osnabrueck
country: Germany
city: Pfarrkirchen
country: Germany
city: Regensburg
country: Germany
city: Schwabach
country: Germany
city: Tangermünde
country: Germany
city: Wuppertal
country: Germany
Study officials:
affiliation: Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
name: Walter Zidek, Prof. Dr.
role: STUDY_DIRECTOR
References: