Chronic Kidney DiseasesPeTRANCT02539680
Intestinal Phosphate Transporter Expression in CKD Patients
A study testing endoscopy in people with Chronic Kidney Diseases, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Upper endoscopy for suspected or known esophageal or gastric pathology
- Upper endoscopy for screening purposes
- Written consent to take part in the study
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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.
Read the 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
- Chronic Kidney Diseases
- Being tested
- endoscopy
- Keywords
- Phosphate transporter, CKD, duodenal biopsies
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyProcedure or surgery
duodenal biopsies
| Study group | Role | What they receive |
|---|---|---|
| normal renal function | Experimental | Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level. Receives: 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. Receives: Procedure: endoscopy |
| on dialysis | Experimental | Evaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level. Receives: Procedure: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the expression level of phosphate transporters in the duodenal of the populations
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2017
- Study completionNov 2017
Why it stopped: insufficiant recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Georg Schlieper, PD Dr.med., Principal investigator, Clinic for Renal and Hypertensive Disorders, Rheumatological and Immunological Diseases (Medical Clinic II)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539680
- Sponsor's protocol ID
- 14-145
- Acronym
- PeTRA
- Status last verified
- Apr 2017
- First submitted
- 25 Aug 2015
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15284307Lee 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.
PubMed 24496589Marks 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.
PubMed 23666413
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Study on Intestinal Phosphate-TRAnsporter Expression in CKD Patients
- ClinicalTrials.gov ID
- NCT02539680
- Acronym / sponsor ID
- PeTRA / 14-145
- Conditions
- Chronic Kidney Diseases
- Keywords
- Phosphate transporter, CKD, duodenal biopsies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficiant recruitment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Chugai Pharmaceutical
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal renal function | Experimental | Procedure: endoscopyEvaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level. |
| CKD stage 3-5 (not on dialysis) | Experimental | Procedure: endoscopyEvaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level. |
| on dialysis | Experimental | Procedure: endoscopyEvaluation of the expression level of phosphate transporters at the mRNA and, if possible, on the protein level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Upper endoscopy for suspected or known esophageal or gastric pathology
- Upper endoscopy for screening purposes
- Written consent to take part in the study
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopyduodenal biopsies | Procedure or surgery | CKD stage 3-5 (not on dialysis), normal renal function, on dialysis |
Primary outcome
Differences in the expression level of phosphate transporters in the duodenal of the populations
Time frame: 5 months
Results and safety
The study was stopped early (reason given: insufficiant recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Background: PubMed 15284307Block 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.
- Background: PubMed 24496589Lee 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.
- Background: PubMed 23666413Marks 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Schlieper, PD Dr.med. principal investigator
Clinic for Renal and Hypertensive Disorders, Rheumatological and Immunological Diseases (Medical Clinic II)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy in people with Chronic Kidney Diseases, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficiant recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the expression level of phosphate transporters in the duodenal of the populations (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539680, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.