NCT02539680

Brief Summary

The aim of the present study is to study the expression of the various phosphate transporters in patients with normal or moderately impaired renal function or in patients on dialysis. In particular, the investigators want to clarify whether NaPi-IIb expression level decreases in CKD patients, which would render it a potentially inadequate pharmaceutical target in these patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

August 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 24, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

August 25, 2015

Last Update Submit

November 22, 2017

Conditions

Chronic Kidney Diseases

Keywords

Phosphate transporterCKDduodenal biopsies

Outcome Measures

Primary Outcomes (1)

  • Differences in the expression level of phosphate transporters in the duodenal of the populations

    5 months

Study Arms (3)

normal renal function

EXPERIMENTAL

Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.

Procedure: endoscopy

CKD stage 3-5 (not on dialysis)

EXPERIMENTAL

Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.

Procedure: endoscopy

on dialysis

EXPERIMENTAL

Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.

Procedure: endoscopy

Interventions

endoscopyPROCEDURE

duodenal biopsies

CKD stage 3-5 (not on dialysis)normal renal functionon dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Upper endoscopy for suspected or known esophageal or gastric pathology
  • Upper endoscopy for screening purposes
  • Written consent to take part in the study

You may not qualify if:

  • Food intake within 8 hours prior to the endoscopy
  • Major duodenal pathology, in particular duodenitis or duodenal ulcers or tumor
  • Contraindication to duodenal biopsy such as bleeding disorder
  • Treatment with medication known to regulate the expression or activity of intestinal phosphate transporters (e.g. nicotinamide)
  • Kidney transplant patients
  • Alcohol or drug abuse
  • Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Participation in a parallel clinical trial
  • Subjects who are in any state of dependency to the sponsor or the investigators
  • Employees of the sponsor or the investigators
  • Subjects who have been committed to an institution by legal or regulatory order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (3)

  • Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2.

    PMID: 15284307BACKGROUND

  • Lee GJ, Marks J. Intestinal phosphate transport: a therapeutic target in chronic kidney disease and beyond? Pediatr Nephrol. 2015 Mar;30(3):363-71. doi: 10.1007/s00467-014-2759-x. Epub 2014 Feb 5.

    PMID: 24496589BACKGROUND

  • Marks J, Debnam ES, Unwin RJ. The role of the gastrointestinal tract in phosphate homeostasis in health and chronic kidney disease. Curr Opin Nephrol Hypertens. 2013 Jul;22(4):481-7. doi: 10.1097/MNH.0b013e3283621310.

    PMID: 23666413BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Georg Schlieper, PD Dr.med.

    Clinic for Renal and Hypertensive Disorders, Rheumatological and Immunological Diseases (Medical Clinic II)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 3, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

November 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)