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Nicotinamide in Hemodialysis Patients With Hyperphosphatemia (DONATO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01200784
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Medice Arzneimittel Pütter GmbH & Co KG

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hemodialysis Hyperphosphatemia Drug: Nicotinamide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 250 mg/d modified release Nicotinamide Drug: Nicotinamide
dosage
Experimental: 500 mg/d modified release Nicotinamide Drug: Nicotinamide
dosage
Experimental: 750 mg/d modified release Nicotinamide Drug: Nicotinamide
dosage
Experimental: 1000 mg/d modified release Nicotinamide Drug: Nicotinamide
dosage
Active Comparator: 1000 mg/d immidiate release Nicotinamide Drug: Nicotinamide
dosage


Outcome Measures
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Primary Outcome Measures :
  1. serum phosphate [ Time Frame: 4 weeks of active treatment ]

Secondary Outcome Measures :
  1. serum phosphate [ Time Frame: 8 weeks of active treatment ]
  2. serum calcium [ Time Frame: 4 and 8 weeks of acitve treatment ]
  3. serum PTH [ Time Frame: 4 and 8 weeks of active treatment ]
  4. adverse events [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200784


Locations
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Germany
Alsfeld, Germany, 36304
Arnstadt, Germany, 99310
Augsburg, Germany, 86157
Berlin Hellersdorf, Germany, 12627
Berlin Kreuzberg, Germany, 10245
Berlin, Germany, 12045
Berlin, Germany, 12203
Berlin, Germany, 12435
Berlin, Germany, 13051
Bielefeld, Germany, 33602
Coburg, Germany, 96450
Darmstadt, Germany, 64295
Dortmund, Germany, 44135
Dülmen, Germany, 48249
Düsseldorf, Germany, 40210
Elsenfeld, Germany, 63820
Erfurt, Germany, 99089
Essen, Germany, 45127
Friedrichsroda, Germany, 99894
Hamburg, Germany, 22297
Hameln, Germany, 31787
Herne, Germany, 44623
Herzberg, Germany, 04916
Iserlohn, Germany, 58638
Jena-Drakendorf, Germany, 07751
Kamen, Germany, 59174
Leverkusen, Germany, 51373
Mannheim, Germany, 68309
Minden, Germany, 32429
Nordhausen, Germany, 99734
Osnabrueck, Germany, 49074
Pfarrkirchen, Germany, 84347
Regensburg, Germany, 93053
Schwabach, Germany, 91126
Tangermünde, Germany, 39590
Wuppertal, Germany, 42283
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
Investigators
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Study Director: Walter Zidek, Prof. Dr. Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
More Information
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Responsible Party: Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier: NCT01200784    
Other Study ID Numbers: 6520-9961-03
2009-015821-34 ( EudraCT Number )
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Niacinamide
Niacin
Nicotinic Acids
 Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents