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OpenTrials
Completed

NCT Number: NCT01200784

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Hyperphosphatemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alsfeld, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotinamide

Drug

dosage

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

Sponsors and collaborators

Lead sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Industry

Registry information

Official study title

Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

Acronym: DONATO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2010
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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