Clinical Trials Directory

Trials / Terminated

TerminatedNCT02539680

Intestinal Phosphate Transporter Expression in CKD Patients

Joint Study on Intestinal Phosphate-TRAnsporter Expression in CKD Patients

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
RWTH Aachen University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed description

Elevated serum phosphate is a potent predictor of death and cardiovascular events in patients with renal disease. Control of serum-phosphate to desired target ranges is insufficient in many patients with advanced chronic kidney disease (CKD), in particular dialysis patients despite dietary restrictions, optimized dialysis regimens and the use of phosphate binders. One reason why for example, phosphate binders are insufficient to control phosphate uptake in the intestine or why they even loose efficacy, is a compensatory upregulation of phosphate transporters in the gut wall. 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

Interventions

TypeNameDescription
PROCEDUREendoscopyduodenal biopsies

Timeline

Start date
2015-09-01
Primary completion
2017-10-01
Completion
2017-11-01
First posted
2015-09-03
Last updated
2017-11-24

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02539680. Inclusion in this directory is not an endorsement.