Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia
Conditions
Brief summary
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
Interventions
DRUGNicotinamide
dosage
Sponsors
Medice Arzneimittel Pütter GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum phosphate | 4 weeks of active treatment |
Secondary
| Measure | Time frame |
|---|---|
| serum phosphate | 8 weeks of active treatment |
| serum calcium | 4 and 8 weeks of acitve treatment |
| serum PTH | 4 and 8 weeks of active treatment |
| adverse events | 12 weeks |
Countries
Germany
Outcome results
None listed