Nicotinamide in Hemodialysis Patients With Hyperphosphatemia (DONATO)

January 16, 2012 updated by: Medice Arzneimittel Pütter GmbH & Co KG

Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Alsfeld, Germany, 36304
      • Arnstadt, Germany, 99310
      • Augsburg, Germany, 86157
      • Berlin, Germany, 12203
      • Berlin, Germany, 12435
      • Berlin, Germany, 12045
      • Berlin, Germany, 13051
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum phosphate
Time Frame: 4 weeks of active treatment
4 weeks of active treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 12 weeks
12 weeks
serum phosphate
Time Frame: 8 weeks of active treatment
8 weeks of active treatment
serum calcium
Time Frame: 4 and 8 weeks of acitve treatment
4 and 8 weeks of acitve treatment
serum PTH
Time Frame: 4 and 8 weeks of active treatment
4 and 8 weeks of active treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Investigators

  • Study Director: Walter Zidek, Prof. Dr., Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6520-9961-03
  • 2009-015821-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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