Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
DONATO
Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
2 other identifiers
interventional
252
1 country
36
Brief Summary
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 10, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJanuary 18, 2012
January 1, 2012
10 months
September 10, 2010
January 16, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
serum phosphate
4 weeks of active treatment
Secondary Outcomes (4)
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
Study Arms (5)
250 mg/d modified release Nicotinamide
EXPERIMENTAL500 mg/d modified release Nicotinamide
EXPERIMENTAL750 mg/d modified release Nicotinamide
EXPERIMENTAL1000 mg/d modified release Nicotinamide
EXPERIMENTAL1000 mg/d immidiate release Nicotinamide
ACTIVE COMPARATORInterventions
dosage
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Alsfeld, 36304, Germany
Unknown Facility
Arnstadt, 99310, Germany
Unknown Facility
Augsburg, 86157, Germany
Unknown Facility
Berlin, 12045, Germany
Unknown Facility
Berlin, 12203, Germany
Unknown Facility
Berlin, 12435, Germany
Unknown Facility
Berlin, 13051, Germany
Unknown Facility
Bielefeld, 33602, Germany
Unknown Facility
Coburg, 96450, Germany
Unknown Facility
Darmstadt, 64295, Germany
Unknown Facility
Dortmund, 44135, Germany
Unknown Facility
Dülmen, 48249, Germany
Unknown Facility
Düsseldorf, 40210, Germany
Unknown Facility
Elsenfeld, 63820, Germany
Unknown Facility
Erfurt, 99089, Germany
Unknown Facility
Essen, 45127, Germany
Unknown Facility
Friedrichsroda, 99894, Germany
Unknown Facility
Hamburg, 22297, Germany
Unknown Facility
Hamelin, 31787, Germany
Unknown Facility
Hellersdorf, 12627, Germany
Unknown Facility
Herne, 44623, Germany
Unknown Facility
Herzberg, 04916, Germany
Unknown Facility
Iserlohn, 58638, Germany
Unknown Facility
Jena-Drakendorf, 07751, Germany
Unknown Facility
Kamen, 59174, Germany
Unknown Facility
Kreuzberg, 10245, Germany
Unknown Facility
Leverkusen, 51373, Germany
Unknown Facility
Mannheim, 68309, Germany
Unknown Facility
Minden, 32429, Germany
Unknown Facility
Nordhausen, 99734, Germany
Unknown Facility
Osnabrück, 49074, Germany
Unknown Facility
Pfarrkirchen, 84347, Germany
Unknown Facility
Regensburg, 93053, Germany
Unknown Facility
Schwabach, 91126, Germany
Unknown Facility
Tangermünde, 39590, Germany
Unknown Facility
Wuppertal, 42283, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Walter Zidek, Prof. Dr.
Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2010
First Posted
September 14, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2011
Study Completion
July 1, 2011
Last Updated
January 18, 2012
Record last verified: 2012-01