Transplant DysfunctionNCT03123796
Effects of Proton Pump Inhibitors on Kidney Transplant Recipients
An observational study of Transplant Dysfunction and Magnesium Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this study, investigation of the effects of PPI use on the outcome of kidney transplant recipients is aimed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Dysfunction, Magnesium Disorder
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to Nov 2017
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients.
Who may be able to join
- Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists (Only PPI).
- Kidney transplant recipients who used histamine H2 receptor antagonists and did not use proton pump inhibitors (Only H2RA).
- Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists (PPI and H2RA).
- Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists (No Acid Suppressive Treatment).
Who cannot join
- Patients who are unwilling or unable to consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
Istanbul, 34093
About this study
Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this study, investigation of the effects of PPI use on the outcome of kidney transplant recipients is aimed.
Read the detailed description
Use of proton pump inhibitors (PPIs) is frequent among renal transplant recipients due to the common use of glucocorticoids in immunosuppresive regimens after transplantation. Reduced kidney functions and hypomagnesemia with the use of PPIs have been reported in various patient populations. However, few studies examined the effects of PPIs on kidney transplant recipients. Therefore, the aim of this study is to investigate the effects of PPI and/or histamine H2 receptor antagonist use on serum magnesium levels, allograft functions and survival in kidney transplant recipients.
- Conditions
- Transplant Dysfunction, Magnesium Disorder
- Keywords
- chronic rejection, transplant outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Only PPI | Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists. | |
| Only H2RA | Kidney transplant recipients who used only histamine H2 receptor antagonists and did not use proton pump inhibitors. | |
| PPI and H2RA | Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists. | |
| No Acid Suppressive Treatment | Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Measured: 5-10 years
Secondary outcomes (1)
Graft rejection
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startDec 2016
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transplant DysfunctionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Caliskan, Istanbul University
- Investigators
- Yasar Caliskan, MD, Principal investigator, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123796
- Sponsor's protocol ID
- 332
- Status last verified
- Dec 2017
- First submitted
- 19 Apr 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193.
PubMed 26752337van Boekel GA, Kerkhofs CH, van de Logt F, Hilbrands LB. Proton pump inhibitors do not increase the risk of acute rejection. Neth J Med. 2014 Feb;72(2):86-90.
PubMed 24659591
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proton Pump Inhibitors on Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03123796
- Acronym / sponsor ID
- 332
- Conditions
- Transplant Dysfunction, Magnesium Disorder
- Keywords
- chronic rejection, transplant outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 Apr 2017 (actual)
- 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.
Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this study, investigation of the effects of PPI use on the outcome of kidney transplant recipients is aimed.
Detailed description
Use of proton pump inhibitors (PPIs) is frequent among renal transplant recipients due to the common use of glucocorticoids in immunosuppresive regimens after transplantation. Reduced kidney functions and hypomagnesemia with the use of PPIs have been reported in various patient populations. However, few studies examined the effects of PPIs on kidney transplant recipients. Therefore, the aim of this study is to investigate the effects of PPI and/or histamine H2 receptor antagonist use on serum magnesium levels, allograft functions and survival in kidney transplant recipients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Only PPI | – | –Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists. |
| Only H2RA | – | –Kidney transplant recipients who used only histamine H2 receptor antagonists and did not use proton pump inhibitors. |
| PPI and H2RA | – | –Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists. |
| No Acid Suppressive Treatment | – | –Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients.
Key inclusion criteria (4 listed)
- Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists (Only PPI).
- Kidney transplant recipients who used histamine H2 receptor antagonists and did not use proton pump inhibitors (Only H2RA).
- Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists (PPI and H2RA).
- Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists (No Acid Suppressive Treatment).
Key exclusion criteria (1 listed)
- Patients who are unwilling or unable to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft survival
Time frame: 5-10 years
1 secondary outcome
Graft rejection
Time frame: 5-10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Background: PubMed 26752337Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193.
- Background: PubMed 24659591van Boekel GA, Kerkhofs CH, van de Logt F, Hilbrands LB. Proton pump inhibitors do not increase the risk of acute rejection. Neth J Med. 2014 Feb;72(2):86-90.
- 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.
Yasar Caliskan, MD principal investigator
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Dysfunction and Magnesium Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Dec 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Graft survival (time frame: 5-10 years). 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 NCT03123796, which also lists 2 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 27 Dec 2017.