NCT03409757

Brief Summary

This pilot study will be carried out to determine if the regular intake of iron-based Velphoro® by hyperphosphatemia patients influences the microbiome in the oral cavity and/or the gut.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

December 5, 2017

Last Update Submit

November 23, 2020

Conditions

Hyperphosphatemia

Keywords

microbiome

Outcome Measures

Primary Outcomes (1)

  • change in relative abundances of iron depending bacterial species within the microbiome from before Velphoro medication to afterwards

    4 weeks

Secondary Outcomes (1)

  • Change of distribution of bacterial species within the microbiome from baseline to after Velphoro medication

    4 weeks

Study Arms (2)

hemodialysis patients with hyperphosphatemia

* dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool * Velphoro® medication

Drug: VelphoroOther: saliva collectionOther: Supragingival biofilm collectionOther: stool collectionOther: blood collection

control group

\- dental investigation and two sample collections of saliva, gingival biofilm (plaque) and stool

Other: saliva collectionOther: Supragingival biofilm collectionOther: stool collection

Interventions

VelphoroDRUG

4 weeks

Also known as: Sucroferric oxyhydroxide
hemodialysis patients with hyperphosphatemia
saliva collectionOTHER

2 samples

control grouphemodialysis patients with hyperphosphatemia
Supragingival biofilm collectionOTHER

2 samples

Also known as: plaque
control grouphemodialysis patients with hyperphosphatemia
stool collectionOTHER

2 samples

control grouphemodialysis patients with hyperphosphatemia
blood collectionOTHER

2 samples

hemodialysis patients with hyperphosphatemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

hemodialysis patients suffering from hyperphosphatemia and healthy volunteers from the clinical routine in the Department of Operative Dentistry, Periodontology and Preventive Dentistry at the university hospital RWTH Aachen

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • The subject is mentally or legally incapacitated
  • Only for the patient group:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of RWTH Aachen, Department of Medicine II

Aachen, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

gingival biofilm, saliva and stool

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

sucroferric oxyhydroxideTransdermal PatchBlood Specimen Collection

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Equipment and SuppliesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

January 24, 2018

Study Start

February 28, 2018

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations

DE(1)