Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT03409757
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* Age less than 18 years
* 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:
* Never got any phosphate binder
* Allergy to Velphoro®
* Celiac disease or any other chronic inflammatory bowel disease
* Previous major surgery in the gastrointestinal tract
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03409757
Study Brief:
Protocol Section:
NCT03409757