Intestinal Phosphate Transporter Expression in CKD Patients (PeTRA)

November 22, 2017 updated by: RWTH Aachen University

Joint Study on Intestinal Phosphate-TRAnsporter Expression in CKD Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • University Hospital Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: normal renal function
Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.
Procedure: endoscopy
duodenal biopsies
Experimental: 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.
Procedure: endoscopy
duodenal biopsies
Experimental: on dialysis
Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level.
Procedure: endoscopy
duodenal biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in the expression level of phosphate transporters in the duodenal of the populations
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

Chugai Pharmaceutical

Investigators

  • Principal Investigator: Georg Schlieper, PD Dr.med., Clinic for Renal and Hypertensive Disorders, Rheumatological and Immunological Diseases (Medical Clinic II)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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