Intestinal Phosphate Transporter Expression in CKD Patients
NCT ID: NCT02539680
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
18 participants
INTERVENTIONAL
2015-09-30
2017-11-30
Brief Summary
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Detailed Description
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Thus, several companies attempt to specifically interfere with intestinal phosphate transporters, in particular the NaPi-IIb transporter. However, recent Chugai data obtained in experimental CKD challenge the assumption that NaPi-IIb is the major therapeutic target in this situation. In addition to NaPi-IIb, PiT-1 and -2 also might contribute to phosphate transport.
In normal human intestinal mucosa the most prominent expression of all 3 transporters is observed in the duodenum, i.e. an area, which can easily be assessed by endoscopy.
During endoscopy a biopsy for research purposes will be obtained. Chugai will evaluate the expression level of NaPi-IIb, PiT-1, PiT-2, and villin1 at the mRNA and, if possible, the protein level.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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normal renal function
Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.
endoscopy
duodenal biopsies
CKD stage 3-5 (not on dialysis)
Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.
endoscopy
duodenal biopsies
on dialysis
Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.
endoscopy
duodenal biopsies
Interventions
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endoscopy
duodenal biopsies
Eligibility Criteria
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Inclusion Criteria
* Upper endoscopy for screening purposes
* Written consent to take part in the study
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Chugai Pharmaceutical
INDUSTRY
RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Georg Schlieper, PD Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Clinic for Renal and Hypertensive Disorders, Rheumatological and Immunological Diseases (Medical Clinic II)
Locations
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University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
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References
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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.
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.
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.
Other Identifiers
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14-145
Identifier Type: -
Identifier Source: org_study_id