Hyperphosphatemia
Conditions
Interventions
Trade Name: Velphoro
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Ferrum
CAS Number: 7439-89-6
Other descriptive name: IRON
Concentration unit: mg milligram(s)
Concentration number: 500-
Sponsors
RWTH Aachen, represented by the rector, himself represented by the dean of the Medical Faculty
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: • Suffering from hyperphosphatemia • Current treatment with a stable dose of a non-iron containing phosphate binder • No or only parenteral iron application • Age of = 18 years • Written informed consent prior to study participation • The subject is willing and able to follow the procedures outlined in the protocol Control group: • Normal renal function • No hyperphosphatemia • Age- and sex-matched and oral disease status-matched (dental caries and periodontal disease) in comparison to the hyperphosphatemia group • Written informed consent prior to study participation • The subject is willing and able to follow the procedures outlined in the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: • Currently on oral iron application • Antibiotic treatment within the last two months • Severe medical events within the last three months • Planned surgery for the duration of the sampling • Acute/chronic gastrointestinal infections • Smokers • Oral candidiasis • Oral cancer • Pregnant and lactating females • Haemochromatosis history • Committed to an institution by legal or regulatory order • Participation in a parallel interventional clinical trial • Receipt of an investigational drug within 30 days prior to inclusion into this study • The subject is mentally or legally incapacitated Only for the patient group: • Allergy to Velphoro® • Never got any phosphate binder • Celiac disease or any other chronic inflammatory bowel disease • Previous major surgery in the gastrointestinal tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of abundances and relative frequencies of distinct bacteria in the collected samples from patients and the control group. Based on these data, potential shifts in the microbiome during Velphoro® medication will be assessed.;Secondary Objective: Determination of diversity measures describing the distribution of bacterial species within the microbiome (i. e. alpha-diversity, beta-diversity, Simpson index, Shannon-Wiener index), as well as the presence or absence of other medically relevant bacterial species (e,g, Pseudomonas, Enterobacteriaceae, Campylobacter etc.).;Primary end point(s): A significant shift (non-parametric Mann-Whitney-U test) in the relative abundance of iron-depending bacterial species will reject the 0-hypothesis;Timepoint(s) of evaluation of this end point: screening, 1 week, 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - A significant shift in total bacterial cell numbers - A significant shift in species diversity - A significant change in clinical parameters, including dental. ;Timepoint(s) of evaluation of this end point: screening, 1 week, 4 weeks | — |
Countries
Germany
Contacts
Public ContactIrina Prell
Center for Translational & Clinical Research Aachen (CTC-A)
Outcome results
None listed