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Nicotinamide in Hemodialysis Patients With Hyperphosphatemia (DONATO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT01200784
First received: September 10, 2010
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
Hemodialysis
Hyperphosphatemia
 Drug: Nicotinamide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medice Arzneimittel Pütter GmbH & Co KG:

Primary Outcome Measures:
  • serum phosphate [ Time Frame: 4 weeks of active treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum phosphate [ Time Frame: 8 weeks of active treatment ] [ Designated as safety issue: No ]
  • serum calcium [ Time Frame: 4 and 8 weeks of acitve treatment ] [ Designated as safety issue: No ]
  • serum PTH [ Time Frame: 4 and 8 weeks of active treatment ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 252
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200784

Locations
Germany
Alsfeld, Germany, 36304
Arnstadt, Germany, 99310
Augsburg, Germany, 86157
Berlin, Germany, 12045
Berlin, Germany, 12435
Berlin, Germany, 13051
Berlin, Germany, 12203
Berlin Hellersdorf, Germany, 12627
Berlin Kreuzberg, Germany, 10245
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
Study Director: Walter Zidek, Prof. Dr. Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
  More Information

No publications provided

Responsible Party: Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier: NCT01200784     History of Changes
Other Study ID Numbers: 6520-9961-03, 2009-015821-34
Study First Received: September 10, 2010
Last Updated: January 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 16, 2013