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Effects of Proton Pump Inhibitors on Kidney Transplant Recipients

NCT ID: NCT03123796

Last Updated: 2017-12-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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

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Transplant Dysfunction Magnesium Disorder

Keywords

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chronic rejection transplant outcome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Only PPI

Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists.

No interventions assigned to this group

Only H2RA

Kidney transplant recipients who used only histamine H2 receptor antagonists and did not use proton pump inhibitors.

No interventions assigned to this group

PPI and H2RA

Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists.

No interventions assigned to this group

No Acid Suppressive Treatment

Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Patients who are unwilling or unable to consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Yasar Caliskan

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasar Caliskan, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Locations

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Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26752337 (View on PubMed)

van 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.

Reference Type BACKGROUND
PMID: 24659591 (View on PubMed)

Other Identifiers

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332

Identifier Type: -

Identifier Source: org_study_id