Effects of Proton Pump Inhibitors on Kidney Transplant Recipients

December 25, 2017 updated by: Yasar Caliskan, Istanbul University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

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

  • Turkey
      • İstanbul, Turkey, 34093
        • Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients.

Description

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.

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft survival
Time Frame: 5-10 years
5-10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Graft rejection
Time Frame: 5-10 years
5-10 years

Other Outcome Measures

Outcome Measure
Time Frame
Serum magnesium levels
Time Frame: 5-10 years
5-10 years

Collaborators and Investigators

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

Sponsor

Istanbul University

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)

December 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 25, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 332 (NIHR School for Primary Care Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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