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Nicotinamide in Hemodialysis Patients With Hyperphosphatemia (DONATO)

Primary Purpose

Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Nicotinamide
Sponsored by
Medice Arzneimittel Pütter GmbH & Co KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

250 mg/d modified release Nicotinamide

500 mg/d modified release Nicotinamide

750 mg/d modified release Nicotinamide

1000 mg/d modified release Nicotinamide

1000 mg/d immidiate release Nicotinamide

Arm Description

Outcomes

Primary Outcome Measures

serum phosphate

Secondary Outcome Measures

serum phosphate
serum calcium
serum PTH
adverse events

Full Information

First Posted
September 10, 2010
Last Updated
January 16, 2012
Sponsor
Medice Arzneimittel Pütter GmbH & Co KG
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1. Study Identification

Unique Protocol Identification Number
NCT01200784
Brief Title
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Acronym
DONATO
Official Title
Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medice Arzneimittel Pütter GmbH & Co KG

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
250 mg/d modified release Nicotinamide
Arm Type
Experimental
Arm Title
500 mg/d modified release Nicotinamide
Arm Type
Experimental
Arm Title
750 mg/d modified release Nicotinamide
Arm Type
Experimental
Arm Title
1000 mg/d modified release Nicotinamide
Arm Type
Experimental
Arm Title
1000 mg/d immidiate release Nicotinamide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Nicotinamide
Intervention Description
dosage
Primary Outcome Measure Information:
Title
serum phosphate
Time Frame
4 weeks of active treatment
Secondary Outcome Measure Information:
Title
serum phosphate
Time Frame
8 weeks of active treatment
Title
serum calcium
Time Frame
4 and 8 weeks of acitve treatment
Title
serum PTH
Time Frame
4 and 8 weeks of active treatment
Title
adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Zidek, Prof. Dr.
Organizational Affiliation
Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
Official's Role
Study Director
Facility Information:
City
Alsfeld
ZIP/Postal Code
36304
Country
Germany
City
Arnstadt
ZIP/Postal Code
99310
Country
Germany
City
Augsburg
ZIP/Postal Code
86157
Country
Germany
City
Berlin Hellersdorf
ZIP/Postal Code
12627
Country
Germany
City
Berlin Kreuzberg
ZIP/Postal Code
10245
Country
Germany
City
Berlin
ZIP/Postal Code
12045
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Berlin
ZIP/Postal Code
12435
Country
Germany
City
Berlin
ZIP/Postal Code
13051
Country
Germany
City
Bielefeld
ZIP/Postal Code
33602
Country
Germany
City
Coburg
ZIP/Postal Code
96450
Country
Germany
City
Darmstadt
ZIP/Postal Code
64295
Country
Germany
City
Dortmund
ZIP/Postal Code
44135
Country
Germany
City
Dülmen
ZIP/Postal Code
48249
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
City
Elsenfeld
ZIP/Postal Code
63820
Country
Germany
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
City
Essen
ZIP/Postal Code
45127
Country
Germany
City
Friedrichsroda
ZIP/Postal Code
99894
Country
Germany
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
City
Hameln
ZIP/Postal Code
31787
Country
Germany
City
Herne
ZIP/Postal Code
44623
Country
Germany
City
Herzberg
ZIP/Postal Code
04916
Country
Germany
City
Iserlohn
ZIP/Postal Code
58638
Country
Germany
City
Jena-Drakendorf
ZIP/Postal Code
07751
Country
Germany
City
Kamen
ZIP/Postal Code
59174
Country
Germany
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
City
Mannheim
ZIP/Postal Code
68309
Country
Germany
City
Minden
ZIP/Postal Code
32429
Country
Germany
City
Nordhausen
ZIP/Postal Code
99734
Country
Germany
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
City
Pfarrkirchen
ZIP/Postal Code
84347
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Schwabach
ZIP/Postal Code
91126
Country
Germany
City
Tangermünde
ZIP/Postal Code
39590
Country
Germany
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany

12. IPD Sharing Statement

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Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

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