Effects of Proton Pump Inhibitors on Kidney Transplant Recipients

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT03123796
Collaborator
(none)
300
1
11
27.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Effects of Proton Pump Inhibitors on Kidney Transplant Recipients
    Actual Study Start Date :
    Dec 1, 2016
    Actual Primary Completion Date :
    Sep 1, 2017
    Actual Study Completion Date :
    Nov 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Graft survival [5-10 years]

    Secondary Outcome Measures

    1. Graft rejection [5-10 years]

    Other Outcome Measures

    1. Serum magnesium levels [5-10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine İstanbul Turkey 34093

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Principal Investigator: Yasar Caliskan, MD, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yasar Caliskan, Associate Professor of Medicine, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT03123796
    Other Study ID Numbers:
    • 332
    First Posted:
    Apr 21, 2017
    Last Update Posted:
    Dec 27, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yasar Caliskan, Associate Professor of Medicine, Istanbul University

    Study Results

    No Results Posted as of Dec 27, 2017