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CompletedNCT01200784DONATOUpdated Jan 18, 2012

Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

A Phase 2 interventional study of Nicotinamide in Chronic Kidney Disease, Hemodialysis and Hyperphosphatemia, sponsored by Medice Arzneimittel Pütter GmbH & Co KG. Completed at 36 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-18.

Sponsored by Medice Arzneimittel Pütter GmbH & Co KG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Kidney Disease
  • Hemodialysis
  • Hyperphosphatemia
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 252 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Medice Arzneimittel Pütter GmbH & Co KG is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
252 participants (actual)

Study arms

  • Experimental
    250 mg/d modified release Nicotinamide

    Drug: Nicotinamide

  • Experimental
    500 mg/d modified release Nicotinamide

    Drug: Nicotinamide

  • Experimental
    750 mg/d modified release Nicotinamide

    Drug: Nicotinamide

  • Experimental
    1000 mg/d modified release Nicotinamide

    Drug: Nicotinamide

  • Active comparator
    1000 mg/d immidiate release Nicotinamide

    Drug: Nicotinamide

Interventions

  • DrugNicotinamide

    dosage

06

What researchers measure

Primary outcomes

  1. serum phosphate

    Time frame: 4 weeks of active treatment

Secondary outcomes

  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

07

Study locations

36 sites
  • Alsfeld, 36304, Germany
  • Arnstadt, 99310, Germany
  • Augsburg, 86157, Germany
  • Berlin Hellersdorf, 12627, Germany
  • Berlin Kreuzberg, 10245, Germany
  • Berlin, 12045, Germany
  • Berlin, 12203, Germany
  • Berlin, 12435, Germany
  • Berlin, 13051, Germany
  • Bielefeld, 33602, Germany
  • Coburg, 96450, Germany
  • Darmstadt, 64295, Germany
  • Dortmund, 44135, Germany
  • Dülmen, 48249, Germany
  • Düsseldorf, 40210, Germany
  • Elsenfeld, 63820, Germany
  • Erfurt, 99089, Germany
  • Essen, 45127, Germany
  • Friedrichsroda, 99894, Germany
  • Hamburg, 22297, Germany
  • Hameln, 31787, Germany
  • Herne, 44623, Germany
  • Herzberg, 04916, Germany
  • Iserlohn, 58638, Germany
  • Jena-Drakendorf, 07751, Germany
  • Kamen, 59174, Germany
  • Leverkusen, 51373, Germany
  • Mannheim, 68309, Germany
  • Minden, 32429, Germany
  • Nordhausen, 99734, Germany
  • Osnabrueck, 49074, Germany
  • Pfarrkirchen, 84347, Germany
  • Regensburg, 93053, Germany
  • Schwabach, 91126, Germany
  • Tangermünde, 39590, Germany
  • Wuppertal, 42283, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01200784
Lead sponsor
Medice Arzneimittel Pütter GmbH & Co KG
Responsible party
Sponsor
First posted
Sep 14, 2010
Start date
Aug 2010
Primary completion
Jun 2011
Completion
Jul 2011
Last update
Jan 18, 2012

Study contacts

Walter Zidek, Prof. Dr.
study director · Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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